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OriGen Biomedical, Inc.

United States·US-MF-000018098

Last updated September 17, 2026

Information

Country: United States
Address: 2215, Grand Avenue Parkway, Austin, United States
Website: www.origen.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 512-474-7278
PRRC Contact: Sam Saleh
EUDAMED SRN: US-MF-000018098
FDA FEI Number: 1000160256
DUNS Number: —

Catalogue (263)

Page 4 of 6

Device	Model / Reference	Registries	Class	Status
Cryostore	CS50Y3	FDA UDI	Class II	Unknown
CryoStore Freezing Bag	CS50M3	FDA UDI	Class II	Active
CryoStore	CS250S	FDA UDI	Class II	Active
Accessories	S-M50	FDA UDI	Class I	Active
Cryostore	CS50N	FDA UDI	Class II	Active
Cell Connect	CC1	FDA UDI	Class I	Active
Cryostore	CS500NSWT	FDA UDI	Class II	Unknown
Cryostore	CS25N	FDA UDI	Class II	Active
TubeSet Adapter	2M-M17	FDA UDI	Class I	Unknown
Accessories	15-RF20-T	FDA UDI	Class I	Active
Spike Adapter	S-M10	FDA UDI	Class I	Unknown
Cryostore	CS250F7P	FDA UDI	Class II	Unknown
Evolve Cell Culture Bag	EV120 + F-M12	FDA UDI	Class I	Active
Cryostore	CS50	FDA UDI	Class II	Active
Cryostore	CS28F	FDA UDI	Class II	Unknown
Manifold Set	SDv-9M141	FDA UDI	Class I	Unknown
PermaLife	PL325-4G	FDA UDI	U	Active
Cryostore	CS2000aY8SW	FDA UDI	Class II	Unknown
Cryostore	CS50NSW	FDA UDI	Class II	Unknown
Cryostore	CS500M4	FDA UDI	Class II	Unknown
Cryostore	CS25FP	FDA UDI	Class II	Active
Cryostore	CS400	FDA UDI	Class II	Unknown
Cryostore	CS750F5-2	FDA UDI	Class II	Unknown
PermaLife™ Cell Culture Bag	PL30M	FDA UDI	U	Active
Cryostore	CS750NSWT	FDA UDI	Class II	Unknown
CryoStore Freezing Bag	CS500	FDA UDI	Class II	Active
Catheter w/ Blunt Introducer	VV23F	FDA UDI	Class II	Unknown
PermaLife	PL2000P2	FDA UDI	U	Unknown
Cryostore	CS50SW	FDA UDI	Class II	Unknown
Cryostore	CS500	FDA UDI	Class II	Active
Cryostore	CS250F1A	FDA UDI	Class II	Unknown
Cryostore	CS50-3	FDA UDI	Class II	Unknown
Spike Adapter	F-8S100	FDA UDI	Class I	Active
Cryostore	CS750F5	FDA UDI	Class II	Unknown
Cryostore	CS750M2S	FDA UDI	Class II	Unknown
CryoStore Freezing Bag	CS25XN	FDA UDI	Class II	Active
Cryostore	CS25Y2	FDA UDI	Class II	Unknown
Cryostore	CS1950aY8SW	FDA UDI	Class II	Unknown
Spike Adapter	S-F15	FDA UDI	Class I	Unknown
Cryostore	CS250i2PW	FDA UDI	Class II	Unknown
Cryostore	CS750M2SW	FDA UDI	Class II	Unknown
PermaLife	PL240	FDA UDI	U	Unknown
PermaLife	PL07J	FDA UDI	U	Unknown
Cryostore	CS750Y11	FDA UDI	Class II	Unknown
Manifold Set	4S-4M60	FDA UDI	Class I	Active
TissueVault™ Cell & Tissue Freezing Bag	TV0909	FDA UDI	Class I	Active
CryoStore Freezing Bag	CS30M9	FDA UDI	Class II	Active
TubeSet Adapter	2M-F17	FDA UDI	Class I	Unknown
Spike Adapter	150-S-M	FDA UDI	Class I	Active
CryoStore	CS2000V8S	FDA UDI	Class II	Unknown

Related Companies

Authorised Representatives

Advena Limited MT

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (20)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 19, 2023	Z-1068-2024	—	open, classified	Accessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulted in loss of gamma compatibility, for accessory set syringes that were gamma sterilized, which resulted in yellowed syringes.
Jan 28, 2021	Z-1409-2021	—	terminated	It was identified that tissue culture bags were incorrectly labeled as free of phthalates.
Jun 24, 2019	Z-0318-2021	—	terminated	The firm has become aware that they have distributed product that was expired.
Aug 21, 2018	Z-0184-2019	—	terminated	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Aug 21, 2018	Z-0181-2019	—	terminated	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Aug 21, 2018	Z-0183-2019	—	terminated	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Aug 21, 2018	Z-0102-2019	—	terminated	The catheter failed the endotoxin testing.
Aug 21, 2018	Z-0182-2019	—	terminated	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Aug 21, 2018	Z-0179-2019	—	terminated	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Aug 21, 2018	Z-0180-2019	—	terminated	These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Aug 2, 2017	Z-0021-2018	—	terminated	Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse events resulted in patient injury (blood loss).
Jan 17, 2017	Z-1227-2019	—	terminated	Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Jan 17, 2017	Z-1231-2019	—	terminated	Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Jan 17, 2017	Z-1230-2019	—	terminated	Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Jan 17, 2017	Z-1228-2019	—	terminated	Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Jan 17, 2017	Z-1229-2019	—	terminated	Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Jan 17, 2017	Z-1232-2019	—	terminated	Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the bond between the clear tube and the molded hub. Forcefully rotating the clamp while it is in place may potentially cause an immediate disconnect of the clear tube or lead to a later fatigue failure of the adhesive bond, with subsequent clear tube disconnect from the hub.
Mar 30, 2015	Z-1456-2015	—	terminated	Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.
Mar 30, 2015	Z-0269-2019	—	terminated	Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage
Dec 16, 2002	Z-0055-06	—	terminated	Leak between two lumens causes reduced performance.