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Sterile X-Ray Detectable Gauze Swabs
EUDAMEDClass IIa (EU MDR)
Ref 15-111Model 10cmx10cm、7.5cmx7.5cm、1.25cmx1m、2.5cmx1m、5cmx1m、2.5cmx2m、5cmx2m、10cmx2m、3cmx14.5cm
Identity
- Trade Name
- Sterile X-Ray Detectable Gauze Swabs EUDAMED
- Device Name
- Sterile X-Ray Detectable Gauze Swabs EUDAMED
- Model / Reference
- 10cmx10cm、7.5cmx7.5cm、1.25cmx1m、2.5cmx1m、5cmx1m、2.5cmx2m、5cmx2m、10cmx2m、3cmx14.5cm EUDAMED15-111 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972013961538 EUDAMED
- Basic UDI-DI
- 697201396MU2ASNNNSDG001KD EUDAMED
- Direct Marketing DI
- 06972013961538 EUDAMED
- EMDN Code
- M020199 COTTON GAUZES - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Sterile X-Ray Detectable Gauze Swabs by Multigate 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 | 697201396MU2ASNNNSDG001KD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Multigate Co., Ltd
- EUDAMED SRN
- CN-MF-000002513
- Authorised Representative
- RFX+Care International A/S DK-AR-000001768
Sources (2)
- EUDAMED e4e611ff-9ef9-4822-bde7-9c67f067dc4e 61 fields · synced Jun 18, 2026
- EUDAMED e9e0a30d-01ff-43ac-a16f-adfae0a346cd 61 fields · synced Jun 18, 2026