Identity
- Device Name
- Flat Pouches EUDAMED
- Model / Reference
- Flat EUDAMED210 mm×400 mm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973685040958 EUDAMED
- Basic UDI-DI
- 697368504PKDLN013M EUDAMED
- EMDN Code
- S01010101 STERILISATION POUCHES, FLAT, PAPER/PLASTIC FILM 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
Flat Pouches by Fomed Industries Inc — 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 | 697368504PKDLN013M | Class I | Active |
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Manufacturer
- Manufacturer
- Fomed Industries Inc.
- EUDAMED SRN
- CN-MF-000012944
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 38831fc7-91c5-47f9-a61d-165f974f3a52 61 fields · synced Jul 10, 2026