Identity
- Device Name
- Gauze swab without X-Ray EUDAMED
- Model / Reference
- FBHEAL - 1095 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06948788175579 EUDAMED
- Basic UDI-DI
- 694878812005Q5 EUDAMED
- EMDN Code
- M0201050101 COTTON GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa 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
Gauze swab without X-Ray by Hubei Qianjiang Kingphar Medical Material Co., Ltd — Class IIa — 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 | 694878812005Q5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hubei Qianjiang Kingphar Medical Material Co., Ltd
- EUDAMED SRN
- CN-MF-000009051
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 2d52aa0b-6780-4127-87a1-4db091e3fa36 61 fields · synced Jun 18, 2026