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BK Rubber and Plastic Cosmetic Foam Cover
EUDAMEDClass I (EU MDR)
Ref BKFC-6P18RPModel Prosthetic Knee Systems
Identity
- Trade Name
- BK Rubber and Plastic Cosmetic Foam Cover EUDAMED
- Model / Reference
- Prosthetic Knee Systems EUDAMEDBKFC-6P18RP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06978867214028 EUDAMED
- Basic UDI-DI
- 697886721PK000RM EUDAMED
- Direct Marketing DI
- 06978867214028 EUDAMED
- EMDN Code
- Y062499 LOWER EXTREMITY PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
BK Rubber and Plastic Cosmetic Foam Cover by Medi Global Assistive Device Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697886721PK000RM | Class I | Active |
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Manufacturer
- Manufacturer
- Medi Global Assistive Device Co., Ltd.
- EUDAMED SRN
- CN-MF-000034804
- Authorised Representative
- Humiss International B.V. NL-AR-000001490
Sources (1)
- EUDAMED ec8467a4-e605-470d-ba25-54621fdb9c9f 61 fields · synced Jun 18, 2026