Non Sterile Gauze Compresses (Sponges)with XR
by Ağaoğlu Tıbbi Sağlık Tekstil San. ve Tic. A.Ş. 5 variants
Ref SN(NS)XRModel 8CMX18CM 16 KAT XR LI, 7,5 CM X 20 CM 12 KAT XR LI, 7,5 CM X 7,5 CM 8 KAT XR LI 10 LU PK, 7,5 CM X 12,5 CM 12 KAT X-RAYLI, 10CMX20CM 12 KAT XR LI, 7,5CMX10CM 12 KAT XR, 5 CM X 15 CM 16 KAT XR'LI
Active
CE MDD
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD | NumberB-08696921062535 | Date5 Apr 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD Active
Specification
- Device Name
- Ağaoğlu Gaz Kompres ( Spanç )
- Model / Reference
- 8CMX18CM 16 KAT XR LI, SN(NS)XR, 7, 5 CM X 20 CM 12 KAT XR LI, 5 CM X 7, 5 CM 8 KAT XR LI 10 LU PK, 5 CM X 12, 5 CM 12 KAT X-RAYLI, 10CMX20CM 12 KAT XR LI, 5CMX10CM 12 KAT XR, 5 CM X 15 CM 16 KAT XR'LI
- Primary DI / UDI-DI
- 08696921062535, 08696921061330, 08696921063440, 08696921061873, 08696921064539, 08696921061798, 08696921062320
- Basic UDI-DI
- B-08696921062535, B-08696921061330, B-08696921063440, B-08696921061873, B-08696921064539, B-08696921061798, B-08696921062320
- EMDN Code
- M0201020202 Cotton gauzes, folded, with x-ray detectable thread, non-sterile
- Device Class
- Class IIa
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000016023
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Properties
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No