TYVEK STERILIZATION REEL 40cm*70mt
by Ftm Ambalaj Medi̇kal İth. İhr. San. Ve Ti̇c.ltd. Şti̇
Ref FTM-00-041Model TYVEK STREILIZATION REEL
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Overview
This TYVEK STERILIZATION REEL 40cm*70mt device features advanced sterile processing capabilities, making it an ideal solution for medical and healthcare applications. With its Class I sterilization status and standardized manufacturing process, this device is designed to provide high-quality products that meet strict regulatory requirements.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number868116145TYSRQ9 08681161450419 | Date25 Jun 2024 | 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- Withdrawn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
- Model / Reference
- TYVEK STREILIZATION REEL, FTM-00-041
- Primary DI / UDI-DI
- 08681161450419
- Basic UDI-DI
- 868116145TYSRQ9
- Direct Marketing DI
- 08681161450419
- EMDN Code
- S01020201 Flat sterilisation reels, tyvek/plastic film
- Device Class
- Class I
- EU market of registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- TR-MF-000042201
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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