Medibag 90 Mm X 135 Mm
by SterileRight Packaging Mfg.Inc.
Ref P615.03.6004Model P101.03
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 | Number471987804P03NR 05902340984277 | Date15 Feb 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- Withdrawn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
- Device Name
- Paper-Film Sterilization self-seal pouch
- Model / Reference
- P101.03, P615.03.6004
- Primary DI / UDI-DI
- 05902340984277
- Basic UDI-DI
- 471987804P03NR
- EMDN Code
- S01010101 Sterilisation pouches, flat, paper/plastic film
- Device Class
- Class I
- EU market of registration
- Poland
Manufacturer details
- EUDAMED SRN
- TW-MF-000016422
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from SterileRight Packaging Mfg.Inc.
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