PermaLife™ Cell Culture Bag
by OriGen Biomedical Inc. 30 variants
Ref PL240K
Active
CE MDD
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDD EUDAMED | NumberB-10816203021790 10816203021790 | Date22 Mar 2024 | StatusActive |
| United States | GUDID listing GUDID | Number10816203021790 | Date23 Sep 2016 | StatusListed |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- PermaLife™ Cell Culture Bag EUDAMEDPermaLife GUDID
- Generic Name
- Blood/tissue storage/culture container
- Device Name
- PL240K
- Model / Reference
- PL240K
- Primary DI / UDI-DI
- 10816203021790
- Basic UDI-DI
- B-10816203021790
- FDA Product Code
- LPZ
- EMDN Code
- A99 Devices for administration, withdrawal and collection - other
- GMDN Term
- Blood/tissue storage/culture container
- Device Class
- Class IIa EUDAMEDU GUDID
- EU market of registration
- Austria
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | U |
Manufacturer details
- EUDAMED SRN
- US-MF-000018098
- Authorised representative
- Advena Limited MT-AR-000000234
From the manufacturer
Manufacturer's product page: PermaLife® Cell Culture Bag
Other devices from OriGen Biomedical Inc.
Properties
Other properties (17)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Manufacturing Date: No