Identity
- Trade Name
- Cosmea Seamless Underwear M S1 EUDAMED
- Device Name
- Incontinence Underwear EUDAMED
- Model / Reference
- 95821302 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04000576058722 EUDAMED
- Basic UDI-DI
- 4000576UNDERWEARDU EUDAMED
- EMDN Code
- T04010103 INCONTINENCE NAPPIES WITH INTEGRATED FIXING SYSTEM 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
Cosmea Seamless Underwear M S1 by W. Pelz GmbH & Co. KG — 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 | 4000576UNDERWEARDU | Class I | Active |
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Manufacturer
- Manufacturer
- W. Pelz GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005236
Sources (1)
- EUDAMED 606cfac9-e17b-43fb-8e50-56027e64375b 61 fields · synced Jul 10, 2026