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Elbow Sleeve with Nano Bamboo Charcoal
EUDAMEDClass I (EU MDR)
Ref 989-BK-S-CCRef 989-BK-M-CCRef 989-BK-L-CC
Identity
- Trade Name
- Elbow Sleeve with Nano Bamboo Charcoal EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 989-BK-S-CC EUDAMED989-BK-M-CC EUDAMED989-BK-L-CC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269536908 EUDAMED00840269536915 EUDAMED00840269536922 EUDAMED
- Basic UDI-DI
- 08402695CL1038G EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Elbow Sleeve with Nano Bamboo Charcoal by La Pointique Int´l 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 | 08402695CL1038G | Class I | Active |
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Manufacturer
- Manufacturer
- La Pointique Int´l Ltd.
- EUDAMED SRN
- US-MF-000005204
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED 480b9c6a-447c-4a76-945e-075c730b9e5f 61 fields · synced Jul 29, 2026
- EUDAMED 4616fa8f-d125-4c52-9fdb-1fe172a04d23 61 fields · synced May 19, 2026
- EUDAMED f7247a01-0617-440f-bb1f-a3c4782b79af 61 fields · synced May 19, 2026