Binfei
by Zhucheng Binfei Medi-Tek Co., Ltd 319 variants
Ref A00295
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 | Number697626279BF-SPKX 06976262791656 | Date7 Aug 2026 | 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- Withdrawn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
- Sterilization pouch
- Model / Reference
- A00295
- Primary DI / UDI-DI
- 06976262791656
- Basic UDI-DI
- 697626279BF-SPKX
- EMDN Code
- S01010101 Sterilisation pouches, flat, paper/plastic film
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- CN-MF-000048252
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Zhucheng Binfei Medi-Tek Co., Ltd
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