Baui Biotech Co L T D

FDA Filings

This page includes the latest FDA filings for Baui Biotech Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3013514648
• FEI Number: 3013514648
• Name: BAUI BIOTECH CO., LTD.
• Owner & Operator: BAUI BIOTECH CO., LTD.
• Contact Address: 6F., No.6, Sec.1, Zhongxing Rd. Wugu Dist.; New Taipei City TW-TPQ Taipei - District 24872 TW
• Official Correspondent:
  • Herman Jhan
  • 886-2-89769538-154
• US Agent:
  • Ho Shan Wang
  • 623 9864377
  • acmebiotechs@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 6F., No.8, Sec.1, Zhongxing Rd. Wugu Dist.; New Taipei City, Taipei - District, 24872 TW
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 04718005156849 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156832 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156825 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156818 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156801 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156795 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156788 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156771 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156764 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156757 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156740 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156733 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156726 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156719 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156702 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156696 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156689 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156672 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156665 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156658 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156641 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156634 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156627 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156610 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156603 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156597 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156580 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156573 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156566 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156559 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156542 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156535 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156528 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156511 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156504 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156498 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156481 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156474 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252861 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252854 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252847 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252830 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252823 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252816 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252809 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252793 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252786 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252779 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252762 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252755 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252748 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252731 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252724 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04712899252717 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04710577040854 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04710577040847 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04710577040830 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04710577040823 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-10
GUDID 04718005156467 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-09
GUDID 04718005156450 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-09
GUDID 04718005156443 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-09
GUDID 04718005156436 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-09
GUDID 04718005156429 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-09
GUDID 04718005156412 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-09
GUDID 04718005156405 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-09
GUDID 04718005156399 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-09
GUDID 04718005156382 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-09
GUDID 04718005156375 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-09
GUDID 04718005156368 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-09
GUDID 04718005156351 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-09
GUDID 04718005156344 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156337 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156320 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156313 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156306 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156290 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156283 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156276 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156269 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156252 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156245 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156238 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156221 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156214 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156207 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156191 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156184 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156177 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156160 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156153 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156146 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156139 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156122 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156115 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156108 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04718005156092 BAUI BIOTECH CO. LTD.	NOVA Minimally Invasive System	2020-11-06
GUDID 04710577041479 BAUI BIOTECH CO. LTD.	COMET Lumbar Interbody Fusion Cage	2020-10-14
GUDID 04710577041462 BAUI BIOTECH CO. LTD.	COMET Lumbar Interbody Fusion Cage	2020-10-14
GUDID 04710577041455 BAUI BIOTECH CO. LTD.	COMET Lumbar Interbody Fusion Cage	2020-10-14
GUDID 04710577041448 BAUI BIOTECH CO. LTD.	COMET Lumbar Interbody Fusion Cage	2020-10-14
PMN K191353 BAUI Biotech Co., Ltd.	COMET Lumbar Interbody Fusion Cage	2020-04-14
PMN K191494 Baui Biotech Co., Ltd.	Facilis™ Spinal System	2019-08-12
PMN K182416 BAUI Biotech CO., LTD.	NOVA Minimally Invasive System	2019-06-11
LXH BAUI BIOTECH CO., LTD.	compression Device	2017-10-27
LXH BAUI BIOTECH CO., LTD.	T-type Torque Wrench	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Sensor	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Rod Template	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Rod Pusher	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Rod Pusher 5mm Hex Simple Screw Driver	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Rod Holder	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Rod Bender	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Reduction Forceps	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Probe	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Probe(curved)	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Poly Axial Screw Driver	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Poly Axial Screw Driver/Cannulated Screw	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Poly Axial Screw Adjustable Driver	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Mono Axial Screw Driver	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Handle	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Gun-type Pull-up Pliers	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Distraction Device	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Development Pin Implanter	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Depth Sounder	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Blade Breaker	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Bending Iron, right	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Bending Iron, left	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Awl(with stop)	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Anti-Rotator Wrench	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Anti-Rotator Pliers	2017-10-27
LXH BAUI BIOTECH CO., LTD.	Adjustable Rod Bender	2017-10-27
LXH BAUI BIOTECH CO., LTD.	8mm Hex Socket Screw Driver	2017-10-27
LXH BAUI BIOTECH CO., LTD.	7mm Tap	2017-10-27
LXH BAUI BIOTECH CO., LTD.	6mm Tap	2017-10-27
LXH BAUI BIOTECH CO., LTD.	5mm Tap	2017-10-27
LXH BAUI BIOTECH CO., LTD.	5mm Socket Wrench	2017-10-27
LXH BAUI BIOTECH CO., LTD.	5mm Rotator Bar	2017-10-27
LXH BAUI BIOTECH CO., LTD.	5mm Hex Screw Driver	2017-10-27
LXH BAUI BIOTECH CO., LTD.	4mm Tap	2017-10-27
LXH BAUI BIOTECH CO., LTD.	4mm Pin Guide	2017-10-27
LXH BAUI BIOTECH CO., LTD.	3mm Hex screw Driver	2017-10-27
PMN K161231 | NKB BAUI BIOTECH CO., LTD.	FACILIS SPINAL SYSTEM	2017-02-13
PMN K161231 | KWP BAUI BIOTECH CO., LTD.	FACILIS SPINAL SYSTEM	2017-02-13
PMN K161231 BAUI BIOTECH CO., LTD.	Facilis™ Spinal System	2017-01-23