Oro Sterilization Self Seal Pouch Hypak 300 X 400 Mm
by Reach Global India Pvt. Ltd.
Ref PSH60PLC65RRT300X400
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 | Number890611232PSH60PLC65RRT8D 89061123281674 | Date4 Sep 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- Withdrawn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 Wraps
- Model / Reference
- PSH60PLC65RRT300X400
- Primary DI / UDI-DI
- 89061123281674
- Basic UDI-DI
- 890611232PSH60PLC65RRT8D
- EMDN Code
- S01010201 Flat sterilisation pouches, tyvek/plastic film
- Device Class
- Class I
- EU market of registration
- Spain
Manufacturer details
- EUDAMED SRN
- IN-MF-000041886
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Reach Global India Pvt. 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