Identity
- Trade Name
- Wewa® Med Sprunggelenkorthese Plus EUDAMED
- Device Name
- Sprunggelenkorthese EUDAMED
- Model / Reference
- 60068 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048486256197 EUDAMED04048486256166 EUDAMED04048486256180 EUDAMED
- Basic UDI-DI
- 4048486230201YA EUDAMED
- Direct Marketing DI
- 04048486256197 EUDAMED04048486256166 EUDAMED04048486256180 EUDAMED
- EMDN Code
- Y06120601 PASSIVE ANKLE-FOOT 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
Category: Ankle/foot orthosis
Wewa® Med Sprunggelenkorthese Plus by Werkmeister GmbH + Co. KG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Ankle/foot orthosis.
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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 | 4048486230201YA | Class I | Active |
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Manufacturer
- Manufacturer
- Werkmeister GmbH + Co. KG
- EUDAMED SRN
- DE-MF-000005120
Sources (3)
- EUDAMED e98ada91-0d7e-4c5a-896a-572561fb3e54 61 fields · synced Jul 31, 2026
- EUDAMED 44500ec0-7998-401d-b711-a1bc159cbe50 61 fields · synced May 19, 2026
- EUDAMED e3a12565-9cd6-4747-bfcd-7c00815dad87 61 fields · synced May 19, 2026