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Sterile gauze swabs
EUDAMEDClass I (EU MDR)
Ref 17C02:5cm×5cm-12PRef 17C02:10cm×10cm-12PRef 10cmx4.5cm-32PRef 10cmx10cm
Identity
- Device Name
- Sterile gauze swabs EUDAMED
- Model / Reference
- 17C02:5cm×5cm-12P EUDAMED17C02:10cm×10cm-12P EUDAMED10cmx4.5cm-32P EUDAMED10cmx10cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973685040286 EUDAMED06973685040293 EUDAMED06973685040798 EUDAMED06973685040736 EUDAMED06973685040767 EUDAMED
- Basic UDI-DI
- 697368504SBPWXCS01FH EUDAMED
- Unit of Use DI
- 06973685040705 EUDAMED
- EMDN Code
- M0201020102 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, NON-STERILE EUDAMEDM0201020101 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMEDEUDAMED
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
Sterile gauze swabs 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 | 697368504SBPWXCS01FH | 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 (5)
- EUDAMED 7c3e03d8-b551-4e9e-a58f-269d5e0f522d 61 fields · synced Aug 3, 2026
- EUDAMED ff3748c1-2c07-4fef-935b-60cc2c655294 61 fields · synced May 19, 2026
- EUDAMED 36271519-b750-43f6-8ed2-2e6722484469 61 fields · synced Jul 11, 2026
- EUDAMED 633af341-65a4-429d-baff-864ab490e245 61 fields · synced Jul 29, 2026
- EUDAMED d3863689-7a9e-47b0-b9a7-bec607bf0e20 61 fields · synced Aug 3, 2026