Identity
- Device Name
- Non-sterile gauze absorbent pad EUDAMED
- Model / Reference
- 10 cmx10 cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973685041108 EUDAMED
- Basic UDI-DI
- 697368504SBXSDFN01B5 EUDAMED
- EMDN Code
- M040201 ABSORBENT DRESSINGS WITH CELLULOSE PAD AND NON-WOVEN WRAPS 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
Non-sterile gauze absorbent pad 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 | 697368504SBXSDFN01B5 | 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 92cff37f-95f6-480c-99ff-605056d7048b 61 fields · synced Jul 10, 2026