Identity
- Device Name
- Hand & Wrist Braces EUDAMED
- Model / Reference
- WAW7104-U-YM-MX1P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04897144890040 EUDAMED
- Basic UDI-DI
- 489714489WAW7104UYMMX1PDJ EUDAMED
- EMDN Code
- Y060618 ELBOW-WRIST ORTHOSES 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
Hand & Wrist Braces by Amitofo Co., Limited — 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 | 489714489WAW7104UYMMX1PDJ | Class I | Active |
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Manufacturer
- Manufacturer
- Amitofo Co., Limited
- EUDAMED SRN
- CN-MF-000045845
- Authorised Representative
- Humiss Beratung GmbH DE-AR-000023447
Sources (1)
- EUDAMED de1bfba4-48ed-445d-977a-7ecbacb18595 61 fields · synced Jul 17, 2026