4a medical
by Dort-A Tip Malz San Ith Ihr Tic Ltd Sti 186 variants
Ref 4AGR500100/60/3
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number86811764SW2 | Date12 Oct 2023 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Trade Name
- 4a medical4a medikal
- Device Name
- Düz Sterilizasyon Rulosu 450 mm x 200 m, 60g 2 İndikatörlü
- Model / Reference
- 4AGR500100/60/3
- Primary DI / UDI-DI
- 08681176422562, 08681176415687
- Basic UDI-DI
- 86811764SW2
- Direct Marketing DI
- 0868117642256208681176415687
- EMDN Code
- S01020102 Sterilisation reels, gusseted, paper/plastic film
- Device Class
- Class I
- EU market of registration
- Romania
Manufacturer details
- EUDAMED SRN
- TR-MF-000019642
Other devices from Dort-A Tip Malz San Ith Ihr Tic Ltd Sti
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Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No