Identity
- Trade Name
- BM EUDAMED
- Device Name
- tiemann catheter EUDAMED
- Model / Reference
- FR6 EUDAMEDBM0607 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974269382150 EUDAMED
- Basic UDI-DI
- B-06974269382150 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 — CE/MDR — 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-06974269382150 | 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 75a8395d-83fa-4c41-9c62-a071a4ed4d6b 61 fields · synced Oct 7, 2026