FDA.reportPublic FDA data

ScopeRemote Medical Scope

Primary DI
06971355353346
Brand
ScopeRemote Medical Scope
Company
Shenzhen BesdataTechnology Co., LTD.
Model
OT-OR007
Device description
Handheld USB video otoscope and intraoral camera, 4.2 mm insertion tube, for visualization of the ear canal, tympanic membrane, and oral cavity. Single-patient use.
Published
2026-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ERAOtoscope
QJKIntraoral Camera

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ERAOtoscopeEar, Nose, Throat1
QJKIntraoral CameraDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16971355350823PackageGS140In Commercial Distribution
06971355353346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697135535082316971355350823
06971355353346069713553533466971355353346

Contacts#

Phone, Email table
PhoneEmail
+1 (404) 832-5149support@scoperemote.com

Regulatory Flags#

DUNS number
418821086
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971355350147BESDATAMil02026-09-04
06971355350154BESDATAMac12026-09-04
06971355350161BESDATAMac32026-09-04
06971355350178BESDATAMac42026-09-04
06971355350512BESDATAD-blade2026-09-04
06971355350529BESDATAMil12026-09-04
06971355350888BESDATAMac22026-09-04
06971355352592BESDATAOT-BR0012026-09-04
06971355352608BESDATAOT-BR0022026-09-04
06971355352615BESDATAOT-BR0032026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00634782102456Diagnostix™AMERICAN DIAGNOSTIC CORPERA2026-10-06
06971355352592BESDATAShenzhen BesdataTechnology Co., LTD.QJK2026-09-04
06971355352608BESDATAShenzhen BesdataTechnology Co., LTD.QJK2026-09-04
06971355352615BESDATAShenzhen BesdataTechnology Co., LTD.QJK2026-09-04
04260381960164LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960188LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960195LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381960218LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381963493LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381963509LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964353LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964360LuxamedLuxamed GmbH & Co. KGERA2026-08-26
04260381964377LuxamedLuxamed GmbH & Co. KGERA2026-08-26
07899581345197Intraoral ScannerAlliage S/A Indústrias Médico OdontológicaQJK2026-08-22
07899581360671Intraoral ScannerAlliage S/A Indústrias Médico OdontológicaQJK2026-08-22
05713315012341Aurical Otocam 300-IIINatus Medical Denmark ApSERA2026-07-20
06972545090485JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
16972545090154JeashiaZhejiang Honsun Medical Technology Co., Ltd.ERA2026-07-17
04260154547271OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547400OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547417OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547424OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547448OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547455OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547462OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547479OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547486OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547493OTOPRONTHappersberger Otopront GmbHERA2026-07-08
04260154547530OTOPRONTHappersberger Otopront GmbHERA2026-07-08
00816063022312iTero Lumina Pro DOAAlign Technology, Inc.QJK2026-06-25