Identity
- Trade Name
- BM EUDAMED
- Device Name
- male catheter EUDAMED
- Model / Reference
- FR8 EUDAMEDBM0617 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974269381580 EUDAMED
- Basic UDI-DI
- B-06974269381580 EUDAMED
- EMDN Code
- U01010502 NELATON CATHETERS, NON SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Bm by Zhejiang Baite Medical Appliances Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06974269381580 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Baite Medical Appliances Co., Ltd.
- EUDAMED SRN
- CN-MF-000021983
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED e85dfda3-607a-4066-8c79-eaff788d90f3 61 fields · synced Jun 18, 2026