Identity
- Trade Name
- PEM Einweg-Gleitfolie EUDAMED
- Device Name
- OnlyU Einweggleitfolie-Schutzfolie EUDAMED
- Model / Reference
- PM-060.70-100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04250355360700 EUDAMED
- Basic UDI-DI
- 42503553DPEM60659172R4 EUDAMED
- Direct Marketing DI
- 04250355360700 EUDAMED
- EMDN Code
- Y99 DEVICES FOR PERSONS WITH DISABILITIES NOT INCLUDED IN OTHER CATEGORIES - 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
PEM Einweg-Gleitfolie by Petermann GmbH — 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 | 42503553DPEM60659172R4 | Class I | Active |
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Manufacturer
- Manufacturer
- Petermann GmbH
- EUDAMED SRN
- DE-MF-000013598
Sources (1)
- EUDAMED 00521533-8f55-48e1-8eb4-c4b14b11d206 61 fields · synced Jul 30, 2026