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PermaLife™ Cell Culture Bag

by OriGen Biomedical Inc. EUDAMEDGUDID

Active European Union and United States

Ref PL120N

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10816203023244 Basic UDI-DIDate22 Mar 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number10816203023244 UDI-DIDate19 May 2017ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDD Expiring
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID

Trade Name
PermaLife™ Cell Culture Bag EUDAMEDGUDID
PermaLife GUDID
Generic Name
Blood/tissue storage/culture container
Device Name
PL120N
Model / Ref / Catalog
PL120N
Primary DI / UDI-DI
10816203023244, 10816203024340
Basic UDI-DI
B-10816203023244
510(k) Number
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 EUDAMED
U GUDID
Market of Registration
Austria
Commercial Distribution
In Commercial Distribution
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
U
Contains LatexEUDAMED
No
GUDID
No
Yes

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.

See all devices from OriGen Biomedical Inc. →

Properties

Show properties
  • Sterile
  • Single Use
  • Contains Latex NoEUDAMEDGUDIDYesGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (16)
  • Implantable: No
  • Reusable: 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