Identity
- Device Name
- Soluble Hemostatic Gauze EUDAMED
- Model / Reference
- 1118 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 26940610112961 EUDAMED
- Basic UDI-DI
- 69406101SG001092 EUDAMED
- Unit of Use DI
- 16940610113305 EUDAMED
- EMDN Code
- M040501 POLYSACCHARIDE HAEMOSTATIC DRESSINGS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
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
Soluble Hemostatic Gauze by Huizhou Foryou Medical Devices Co., Ltd. — Class IIb — 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 | 69406101SG001092 | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Huizhou Foryou Medical Devices Co., Ltd.
- EUDAMED SRN
- CN-MF-000007344
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED cfeb84e0-9761-4c40-ac34-9751ab453d09 61 fields · synced Sep 17, 2026