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Non Sterile Gauze Compresses (Sponges)with XR
EUDAMEDClass IIa (EU MDR)
Ref SN(NS)XRModel 10CMX15CM 16 KAT XR LI
Identity
- Trade Name
- Non Sterile Gauze Compresses (Sponges)with XR EUDAMED
- Device Name
- AĞAOĞLU GAZ KOMPRES ( SPANÇ ) EUDAMED
- Model / Reference
- 10CMX15CM 16 KAT XR LI EUDAMEDSN(NS)XR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08696921061453 EUDAMED
- Basic UDI-DI
- B-08696921061453 EUDAMED
- EMDN Code
- M0201020202 COTTON GAUZES, FOLDED, WITH X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Non Sterile Gauze Compresses (Sponges)with XR by Ağaoğlu Tıbbi Sağlık Tekstil San. ve Tic. A.Ş. — Class IIa — MDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08696921061453 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ağaoğlu Tıbbi Sağlık Tekstil San. ve Tic. A.Ş.
- EUDAMED SRN
- TR-MF-000016023
Sources (1)
- EUDAMED 3be8f0ee-5d43-4628-97b5-5b91ca100b7a 61 fields · synced Oct 6, 2026