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7.5x7.5cm Sterile Gauze swab
EUDAMEDClass I (EU MDR)
Ref FA200-9169Model 2~20x2~20cm
Identity
- Trade Name
- 7.5x7.5cm Sterile Gauze swab EUDAMED
- Device Name
- Sterile Gauze swab EUDAMED
- Model / Reference
- 2~20x2~20cm EUDAMEDFA200-9169 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06922820991693 EUDAMED
- Basic UDI-DI
- 69228209MDN1204IS00004983 EUDAMED
- EMDN Code
- M0201020101 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark 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
7.5x7.5cm Sterile Gauze swab by RFX+CARE Manufacturing Co., Ltd. — 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 | 69228209MDN1204IS00004983 | Class I | Active |
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Manufacturer
- Manufacturer
- RFX+CARE Manufacturing Co., Ltd.
- EUDAMED SRN
- CN-MF-000002971
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (1)
- EUDAMED c3dac446-06ba-45a6-8d83-f9c09045dbc1 61 fields · synced Jun 18, 2026