Identity
- Trade Name
- Bialmed EUDAMED
- Device Name
- Disinfecting Cap EUDAMEDDisinfection Caps EUDAMED
- Model / Reference
- F EUDAMEDDFC002 EUDAMEDDFC001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971564461719 EUDAMED06971564469845 EUDAMED
- Basic UDI-DI
- B-06971564461719 EUDAMEDB-06971564469845 EUDAMED
- EMDN Code
- D0702 ISOPROPYL ALCOHOL FOR THE DISINFECTION OF MEDICAL DEVICES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDPoland 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
Bialmed by Jiangsu Caina Medical 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-06971564461719 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jiangsu Caina Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000011217
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 9b2f5db3-83fe-47f0-a364-e96aaa9e2cfc 61 fields · synced Oct 6, 2026
- EUDAMED 4fc02ab3-6fdd-4e51-9103-dc96b8f9f486 61 fields · synced May 17, 2026