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Single-use Bronchoscope
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref BR-M22Model BR-M58,BR-M52,BR-M50,BR-M40,BR-M32,BR-M25,BR-M22,BR-M58H,BR-M52H,BR-M40H
Identity
- Trade Name
- Single-use Bronchoscope FDA UDI
- Generic Name
- Flexible video bronchoscope, single-use FDA UDI
- Device Name
- Single-use Bronchoscope EUDAMED
- Model / Reference
- BR-M58,BR-M52,BR-M50,BR-M40,BR-M32,BR-M25,BR-M22,BR-M58H,BR-M52H,BR-M40H EUDAMEDBR-M22 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970462541035 EUDAMED06970462546115 FDA UDI
- Basic UDI-DI
- 69704625420167S EUDAMED
- 510(k) Number
- K222910 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- EMDN Code
- Z12020801 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
- Germany 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Single-use Bronchoscope by Shenzhen HugeMed Medical Technical Development Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 69704625420167S | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- EUDAMED SRN
- CN-MF-000010895
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 0c58a292-4e9b-4120-b4a0-92c59e8c8626 61 fields · synced Jul 9, 2026
- FDA UDI ea47eeb7-7dfc-4f7c-8c74-86ed61684dd8 33 fields · synced May 30, 2026