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Flexible Bronchoscopes
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BS50H-20USModel BS41H-12EU, BS41H-12US and etc.Ref BS27U-12EURef BS59H-28USRef BS50H-20EU
Identity
- Trade Name
- Innovex FDA UDI
- Generic Name
- Flexible video bronchoscope, single-use FDA UDI
- Device Name
- Flexible Bronchoscopes EUDAMED
- Model / Reference
- BS41H-12EU, BS41H-12US and etc. EUDAMEDBS50H-20US EUDAMEDFDA UDIBS27U-12EU EUDAMEDBS50H-20EU EUDAMEDFDA UDIBS59H-28US EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970034210475 EUDAMEDFDA UDI06970034210734 EUDAMED06970034210413 EUDAMEDFDA UDI06970034210505 EUDAMEDFDA UDI
- Basic UDI-DI
- 697003421RCVM EUDAMED
- FDA Product Code
- EOQ FDA UDI
- EMDN Code
- Z12020802 VIDEO BRONCHOSCOPES EUDAMED
- GMDN Term
- Flexible video bronchoscope, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Market of Registration
- Ireland EUDAMEDItaly EUDAMEDBelgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Flexible Bronchoscopes by Shanghai Anqing Medical Instrument Co., Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697003421RCVM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Shanghai Anqing Medical Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000008487
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (8)
- EUDAMED a1083f27-1fa0-427d-9107-f865bcc7bb2e 61 fields · synced Oct 6, 2026
- EUDAMED 008d7c85-f4e4-4ef9-b900-9aa1b61eecbd 61 fields · synced May 18, 2026
- FDA UDI de15bb63-de25-43ab-a5ff-9e1972203ef5 32 fields · synced May 24, 2026
- FDA UDI 878d5c85-bdc6-465d-ae60-d85e4924c9bb 32 fields · synced May 30, 2026
- FDA UDI da529ee0-ccd5-4175-8d67-5eaf2d0e5988 32 fields · synced May 30, 2026
- EUDAMED b57ffe07-6d16-4dc6-9624-b81533ed2ed6 61 fields · synced Jul 8, 2026
- EUDAMED ef5457d1-284b-45c9-a1a2-7deac9a67f95 61 fields · synced Jul 16, 2026
- EUDAMED 7e61dfd2-eb82-49a3-a22a-3a34836d8dc8 61 fields · synced Sep 17, 2026