Non Sterile Gauze Compresses (Sponges) without XR
by Ağaoğlu Tıbbi Sağlık Tekstil San. ve Tic. A.Ş. 6 variants
Ref SN(NS)Model 7,5 CM X 17,5 CM 8 KAT, 7,5 CM X 22,5 CM 8 KAT, 5 CM X 5 CM 12 KAT, 5 CM X 80 CM, 10 CM X 10 CM 4 KAT, 7,5 CM X 18 CM 40 KAT, 8CMX18CM 16 KAT, 6 CM X 6 CM 16 KAT
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-08696921061668 | Date4 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- Withdrawn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
- 7, 5 CM X 17, 5 CM 8 KAT, SN(NS), 5 CM X 22, 5 CM X 5 CM 12 KAT, 5 CM X 80 CM, 10 CM X 10 CM 4 KAT, 5 CM X 18 CM 40 KAT, 8CMX18CM 16 KAT, 6 CM X 6 CM 16 KAT
- Primary DI / UDI-DI
- 08696921061668, 08696921062757, 08696921060142, 08696921063327, 08696921063365, 08696921061590, 08696921062528, 08696921062276
- Basic UDI-DI
- B-08696921061668, B-08696921062757, B-08696921060142, B-08696921063327, B-08696921063365, B-08696921061590, B-08696921062528, B-08696921062276
- EMDN Code
- M0201020102 Cotton gauzes, folded, without 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