Bmc Medical Co L T D

FDA Filings

This page includes the latest FDA filings for Bmc Medical 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: 3013505405
• FEI Number: 3013505405
• Name: Marco Mu
• Owner & Operator: BMC Medical Co., Ltd
• Contact Address: Room 901, Building 1 No.28 Pingguoyuan Road; Shijingshan District CN-11 Beijing 100041 CN
• US Agent:
  • Marco Mu
  • Mid-Link International, Inc.
  • 360 3257028
  • 360 9253199
  • info@mid-link.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2219 Rimlang Drive, Suite 301 ; Bellingham, WA 98226 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

• Registration Number: 3008566132
• FEI Number: 3008566132
• Name: BMC MEDICAL CO., LTD
• Owner & Operator: BMC Medical Co., Ltd
• Contact Address: Room 901, Building 1 No.28 Pingguoyuan Road; Shijingshan District CN-11 Beijing 100041 CN
• US Agent:
  • Marco Mu
  • Mid-Link International, Inc.
  • 360 3257028
  • 360 9253199
  • info@mid-link.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Room 901, Building 1 No.28 Pingguoyuan Road, Shijingshan; Beijing Beijing, 100041 CN
• Establishment Type: Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 36948538368115 BMC Medical Co., Ltd.	Siesta 2 Full Face Mask	2024-04-10
GUDID 36948538368092 BMC Medical Co., Ltd.	Siesta 2 Full Face Mask	2024-04-10
GUDID 36948538368085 BMC Medical Co., Ltd.	Siesta 2 Full Face Mask	2024-04-10
GUDID 36948538368078 BMC Medical Co., Ltd.	Siesta 2 Nasal Mask	2024-04-10
GUDID 36948538368061 BMC Medical Co., Ltd.	Siesta 2 Nasal Mask	2024-04-10
GUDID 36948538368054 BMC Medical Co., Ltd.	Siesta 2 Nasal Mask	2024-04-10
GUDID 36948538368047 BMC Medical Co., Ltd.	Siesta 2 Nasal Mask	2024-04-10
GUDID 36948538368030 BMC Medical Co., Ltd.	Siesta 2 Nasal Mask	2024-04-10
GUDID 06948538368107 BMC Medical Co., Ltd.	Siesta 2 Full Face Mask	2024-04-10
GUDID 16948538368326 BMC Medical Co., Ltd.	Rio II Nasal Mask	2024-04-08
GUDID 16948538368319 BMC Medical Co., Ltd.	Rio II Nasal Mask	2024-04-08
GUDID 16948538368302 BMC Medical Co., Ltd.	Rio II Nasal Mask	2024-04-08
GUDID 16948538368296 BMC Medical Co., Ltd.	Rio II Nasal Mask	2024-04-08
GUDID 16948538368289 BMC Medical Co., Ltd.	Rio II Full Face Mask	2024-04-08
GUDID 16948538368272 BMC Medical Co., Ltd.	Rio II Full Face Mask	2024-04-08
GUDID 16948538368265 BMC Medical Co., Ltd.	Rio II Full Face Mask	2024-04-08
GUDID 06948538368251 BMC Medical Co., Ltd.	Rio II Full Face Mask	2024-04-08
GUDID 16948538368173 BMC Medical Co., Ltd.	Rio™ II Nasal Pillows Interface	2023-12-01
GUDID 06948538368183 BMC Medical Co., Ltd.	Siesta Nasal Mask(S)	2023-12-01
GUDID 16948538368241 BMC Medical Co., Ltd.	Siesta Full Face Mask (L)	2023-11-30
GUDID 16948538368234 BMC Medical Co., Ltd.	Siesta Full Face Mask (M)	2023-11-30
GUDID 16948538368227 BMC Medical Co., Ltd.	Siesta Full Face Mask (S)	2023-11-30
GUDID 16948538368210 BMC Medical Co., Ltd.	Siesta Nasal Mask(SML)	2023-11-30
GUDID 16948538368203 BMC Medical Co., Ltd.	Siesta Nasal Mask(L)	2023-11-30
GUDID 16948538368197 BMC Medical Co., Ltd.	Siesta Nasal Mask(M)	2023-11-30
GUDID 06948538368022 BMC Medical Co., Ltd.	Rio II Nasal Pillows Interface	2023-10-27
GUDID 16948538362676 BMC Medical Co., Ltd.	Water chamber	2023-08-29
GUDID 16948538364014 BMC Medical Co., Ltd.	Water chamber	2023-08-14
GUDID 16948538367640 BMC Medical Co., Ltd.	Rio II Nasal Pillows Interface	2023-07-31
GUDID 16948538367633 BMC Medical Co., Ltd.	Rio II Nasal Pillows Interface	2023-07-31
GUDID 16948538367626 BMC Medical Co., Ltd.	Rio II Nasal Pillows Interface	2023-07-31
GUDID 16948538367817 BMC Medical Co., Ltd.	Rio II Nasal Pillows Interface	2023-05-26
GUDID 16948538367800 BMC Medical Co., Ltd.	Rio II Nasal Pillows Interface	2023-05-26
GUDID 16948538367794 BMC Medical Co., Ltd.	Rio II Nasal Pillows Interface	2023-05-26
GUDID 16948538364243 BMC Medical Co., Ltd.	Viva Nasal Mask Replacement Cushion-Small	2023-04-19
GUDID 16948538364236 BMC Medical Co., Ltd.	Viva Nasal Mask Replacement Cushion-Medium	2023-04-19
GUDID 16948538364229 BMC Medical Co., Ltd.	Viva Nasal Mask Replacement Cushion-Large	2023-04-19
GUDID 16948538364212 BMC Medical Co., Ltd.	Rio II Nasal Pillows Interface Replacement Nasal Pillows-S	2023-04-19
GUDID 16948538364205 BMC Medical Co., Ltd.	Rio II Nasal Pillows Interface Replacement Nasal Pillows-M	2023-04-19
GUDID 16948538364199 BMC Medical Co., Ltd.	Rio II Nasal Pillows Interface Replacement Nasal Pillows-L	2023-04-19
GUDID 16948538364182 BMC Medical Co., Ltd.	Rio II Nasal Pillows Interface (without Headgear)-S	2023-04-19
GUDID 16948538364175 BMC Medical Co., Ltd.	Rio II Nasal Pillows Interface (without Headgear)-M	2023-04-19
GUDID 16948538364168 BMC Medical Co., Ltd.	Rio II Nasal Pillows Interface (without Headgear)-L	2023-04-19
GUDID 16948538364274 BMC Medical Co., Ltd.	Numa Full Face Mask Replacement Cushion-Small	2023-04-18
GUDID 16948538364267 BMC Medical Co., Ltd.	Numa Full Face Mask Replacement Cushion-Medium	2023-04-18
GUDID 16948538364250 BMC Medical Co., Ltd.	Numa Full Face Mask Replacement Cushion-Large	2023-04-18
GUDID 16948538364151 BMC Medical Co., Ltd.	Siesta Nasal Mask Replacement Cushion-Small	2023-04-18
GUDID 16948538364144 BMC Medical Co., Ltd.	Siesta Nasal Mask Replacement Cushion-Medium	2023-04-18
GUDID 16948538364137 BMC Medical Co., Ltd.	Siesta Nasal Mask Replacement Cushion-Large	2023-04-18
GUDID 16948538364120 BMC Medical Co., Ltd.	Siesta Nasal Mask Replacement Frame	2023-04-18
GUDID 16948538364113 BMC Medical Co., Ltd.	Siesta Nasal Mask (without Headgear)-S	2023-04-18
GUDID 16948538364106 BMC Medical Co., Ltd.	Siesta Nasal Mask (without Headgear)-M	2023-04-18
GUDID 16948538364090 BMC Medical Co., Ltd.	Siesta Nasal Mask (without Headgear)-L	2023-04-18
GUDID 16948538364281 BMC Medical Co., Ltd.	Blank SD Card for Pap Devices	2023-04-17
GUDID 16948538364083 BMC Medical Co., Ltd.	Siesta Full Face Mask Replacement Cushion	2023-04-17
GUDID 16948538364076 BMC Medical Co., Ltd.	Siesta Full Face Mask Replacement Cushion	2023-04-17
GUDID 16948538364069 BMC Medical Co., Ltd.	Siesta Full Face Mask Replacement Cushion	2023-04-17
GUDID 16948538364052 BMC Medical Co., Ltd.	Siesta Full Face Mask Replacement Frame	2023-04-17
GUDID 16948538364045 BMC Medical Co., Ltd.	Siesta Full Face Mask (without Headgear)-S	2023-04-17
GUDID 16948538364038 BMC Medical Co., Ltd.	Siesta Full Face Mask (without Headgear)-M	2023-04-17
GUDID 16948538364021 BMC Medical Co., Ltd.	Siesta Full Face Mask (without Headgear) -L	2023-04-17
GUDID 16948538363390 BMC Medical Co., Ltd.	Display Shell	2023-03-13
GUDID 16948538363383 BMC Medical Co., Ltd.	AC/DC Power Adapter	2023-03-13
GUDID 16948538363376 BMC Medical Co., Ltd.	Filter Cap	2023-03-13
GUDID 16948538362997 BMC Medical Co., Ltd.	Carrying Case	2023-03-13
GUDID 06948538363362 BMC Medical Co., Ltd.	Auto CPAP System	2023-03-13
GUDID 16948538362904 BMC Medical Co., Ltd.	Cellular Module	2022-11-10
GUDID 16948538362782 BMC Medical Co., Ltd.	Power Cord American Standard	2022-11-10
GUDID 16948538362775 BMC Medical Co., Ltd.	Knob	2022-11-10
GUDID 16948538362768 BMC Medical Co., Ltd.	Knob	2022-11-10
GUDID 16948538362911 BMC Medical Co., Ltd.	/	2022-09-30
GUDID 16948538362850 BMC Medical Co., Ltd.	/	2022-09-30
GUDID 16948538362843 BMC Medical Co., Ltd.	/	2022-09-30
GUDID 16948538362751 BMC Medical Co., Ltd.	/	2022-09-30
GUDID 16948538367619 BMC Medical Co., Ltd.	/	2022-09-07
GUDID 16948538367602 BMC Medical Co., Ltd.	/	2022-09-07
GUDID 16948538367596 BMC Medical Co., Ltd.	/	2022-09-07
GUDID 16948538367589 BMC Medical Co., Ltd.	/	2022-09-07
GUDID 16948538367404 BMC Medical Co., Ltd.	/	2022-09-06
GUDID 16948538367398 BMC Medical Co., Ltd.	/	2022-09-06
GUDID 16948538367381 BMC Medical Co., Ltd.	/	2022-09-06
GUDID 16948538367374 BMC Medical Co., Ltd.	/	2022-09-06
GUDID 16948538367367 BMC Medical Co., Ltd.	/	2022-09-06
GUDID 16948538362669 BMC Medical Co., Ltd.	3B	2022-09-06
GUDID 16948538362652 BMC Medical Co., Ltd.	3B	2022-09-06
GUDID 16948538362645 BMC Medical Co., Ltd.	3B	2022-09-06
GUDID 16948538362560 BMC Medical Co., Ltd.	3B	2022-09-06
GUDID 16948538360719 BMC Medical Co., Ltd.	/	2022-09-06
GUDID 06948538365618 BMC Medical Co., Ltd.	Luna®	2022-09-06
GUDID 06948538365601 BMC Medical Co., Ltd.	Luna®	2022-09-06
GUDID 06948538363348 BMC Medical Co., Ltd.	Luna®	2022-09-06
GUDID 06948538363317 BMC Medical Co., Ltd.	Luna®	2022-09-06
GUDID 06948538363300 BMC Medical Co., Ltd.	Luna®	2022-09-06
GUDID 06948538363294 BMC Medical Co., Ltd.	Luna®	2022-09-06
GUDID 06948538363287 BMC Medical Co., Ltd.	Luna®	2022-09-06
GUDID 06948538363270 BMC Medical Co., Ltd.	Luna®	2022-09-06
GUDID 06948538362549 BMC Medical Co., Ltd.	/ /	2022-09-06
GUDID 16948538362614 BMC Medical Co., Ltd.	3B	2022-09-05
GUDID 16948538362607 BMC Medical Co., Ltd.	3B	2022-09-05
GUDID 16948538362591 BMC Medical Co., Ltd.	3B	2022-09-05
PMN K211155 BMC Medical Co., Ltd.	Auto CPAP System	2022-03-09
BZO Marco Mu [BMC Medical Co., Ltd]	Breathing Tube (L1)	2020-03-29
BZO BMC MEDICAL CO., LTD	Breathing Tube (L1)	2020-03-29
PMN K163464 | BZD Marco Mu [BMC Medical Co., Ltd]	Viva Nasal Mask, Numa Full Face Mask, F2 Single-Patient Vented Full Face Mask	2017-09-05
PMN K163464 | BZD BMC MEDICAL CO., LTD	Viva Nasal Mask, Numa Full Face Mask, F2 Single-Patient Vented Full Face Mask	2017-09-05
PMN K133009 BMC MEDICAL CO., LTD	NASAL MASK, NASAL MASK, FULL FACE MASK	2014-04-23
PMN K131901 | BZD Marco Mu [BMC Medical Co., Ltd]	iOTM Mini Nasal Mask, Siesta full face mask; Siesta nasal mask	2014-01-01
PMN K131901 | BZD BMC MEDICAL CO., LTD	iOTM Mini Nasal Mask, Siesta full face mask; Siesta nasal mask	2014-01-01

Related Finance Registrations

NCAGE Code	SHWZ5	BMC Medical Co., Ltd.
CAGE Code	SHWZ5	BMC MEDICAL CO., LTD.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020080561560	Pusan,South Korea -> Long Beach, California	1.NUMA FULL FACE MASK (BMC-FM2), 600S/3900M/8 00L 2.NUMA FULL FACE MASK REPLACEMENT CUSHION ,600S/2900M/1700L 3.SIESTA NASAL MASK (N5B)-A LL SIZE KIT 4.SIESTA NASAL MASK (N5B), 2500S/ 2500M/2500L 5.RIO II NASAL PILLOWS INTERFACE (P2)-ALL SIZE KIT	1561 CTN
2020073039969	Pusan,South Korea -> Long Beach, California	1. F2 SINGLE-PATIENT VENTED FULL FACE MASK( BMC-FM2 )-SMALL 2. NUMA FULL FACE MASK ( BMC-FM2 )-500S 1000M 500L 3. NUMA FULL FACE MASK REPLACEMENT CUSHION-LARGE 4. RIO II NASAL PILLOWS INTERFACE( P2 )-ALL	1144 CTN
2020022024814	Pusan,South Korea -> Long Beach, California	CPAP AUTO CPAP	2100 CTN
202002075606	Xingang,China (Mainland) -> Long Beach, California	1.SIESTA FULL FACE MASK (F5A)-ALL SIZE KIT 2. E MASK REPLACEMENT HEADGEAR 4.SIESTA FULL FAC E MASK REPLACEMENT CUSHION 5.VIVA NASA	1161 CTN
2020011611482	Xingang,China (Mainland) -> Long Beach, California	CPAP AUTO CPAP RESMART HUMIDIFIER WATER CHAMB ER	2310 CTN
2020011116585	Xingang,China (Mainland) -> Long Beach, California	AUTO CPAP CPAP	1080 CTN
201912076466	Pusan,South Korea -> Long Beach, California	1.F2 SINGLE-PATIENT NON-VENTED FULL FACE MASK MASK(BMC-FM2) 3.NUMA FULL FACE MASK REPLACEM ENT HEADGEAR 4.RIO II NASAL PILLOWS INTERF	1269 CTN
201911092148	Xingang,China (Mainland) -> Jacksonville, Florida	1.CPAP 2.LUNA WATER CHAMBER REPLACEMENT 3.WI- FI MODULE 4.LUNA WI-FI ADHENSIVE 5.LUNA POWER SUPPLY 6.AUTO CPAP 7.RESMART BPAP 25A SYSTEM WITH INTEGRATED HEATED HUMIDIFIER 8.RESMART H UMIDIFIER WATER CHAMBER 9.WATER CHAMBER COMME RCIAL INVOICE NO.:CI-3BP-H1919	1766 CTN