SafeCheck Tyvek® Sterilization Pouch (TYZ7525)
by Medster Tıbbi Cihaz ve Sağlık Hizmetleri Ltd. Şti. 2 variants
Ref TYZ3060
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 | Number868122703RPYJ 08681227034997 | Date5 Nov 2022 | 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- Withdrawn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
- Device Name
- SafeCheck Sterilization Reels and Pouches
- Model / Reference
- TYZ3060
- Primary DI / UDI-DI
- 08681227034997
- Basic UDI-DI
- 868122703RPYJ
- Direct Marketing DI
- 08681227034997
- EMDN Code
- S01010201 Flat sterilisation pouches, tyvek/plastic film
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000014781
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Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: 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