Identity
- Device Name
- Throat Pack EUDAMED
- Model / Reference
- 10 cmx20 m EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973685041139 EUDAMED
- Basic UDI-DI
- 697368504HGMJGN01DA EUDAMED
- EMDN Code
- M020199 COTTON GAUZES - 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
Throat Pack 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 | 697368504HGMJGN01DA | 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 52a1e75d-3d10-40be-9653-4966e9268457 61 fields · synced Jul 24, 2026