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BIOSEAL

Last updated September 17, 2026

Information

Country: US
Address: 167 WEST ORANGETHORPE AVE., PLACENTIA, CA, 92870
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 2027062
DUNS Number: 186968939

Catalogue (1106)

Page 3 of 23

Device	Model / Reference	Registries	Class	Status
Bioseal Inc.	4225RG/25	FDA UDI	Class I	Active
Bioseal Inc.	18003/50	FDA UDI	Class I	Active
Bioseal Inc.	19633/20	FDA UDI	Class I	Active
Bioseal Inc.	17332/25	FDA UDI	Class I	Active
Bioseal Inc.	19912/25	FDA UDI	Class I	Active
Bioseal Inc.	3144/24	FDA UDI	Class I	Active
Bioseal Inc.	19781/20	FDA UDI	Class I	Active
Bioseal Inc.	KI903/25	FDA UDI	Class II	Active
Bioseal Inc.	4425/24	FDA UDI	Class I	Active
Bioseal Inc.	19125/50	FDA UDI	Class I	Active
Bioseal Inc.	4918/100	FDA UDI	Class I	Active
Bioseal Inc.	24-710/20	FDA UDI	Class I	Active
Bioseal Inc.	19989/25	FDA UDI	Class I	Active
Bioseal Inc.	19110/50	FDA UDI	Class I	Active
Bioseal Inc.	19671/20	FDA UDI	Class I	Active
Bioseal Inc.	19725/20	FDA UDI	Class I	Active
Bioseal Inc.	4476/25	FDA UDI	Class I	Active
Bioseal Inc.	540SO/12	FDA UDI	Class I	Active
Bioseal Inc.	17711/25	FDA UDI	Class I	Active
Bioseal Inc.	4066/24	FDA UDI	Class I	Active
Bioseal Inc.	17589/50	FDA UDI	Class I	Active
Bioseal Inc.	27-763A/20	FDA UDI	Class I	Active
Bioseal Inc.	551L/20	FDA UDI	Class I	Active
Bioseal Inc.	27-732/20	FDA UDI	Class I	Active
Bioseal Inc.	4465/20	FDA UDI	Class I	Active
Bioseal Inc.	107500140/01	FDA UDI	Class I	Active
Bioseal Inc.	19715/20	FDA UDI	Class I	Active
Bioseal Inc.	19803/50	FDA UDI	Class II	Active
Bioseal Inc.	17506NS/24	FDA UDI	Class I	Active
Bioseal Inc.	19730/20	FDA UDI	Class I	Active
Bioseal Inc.	4905/25	FDA UDI	Class I	Active
Bioseal Inc.	17773/50	FDA UDI	Class I	Active
Bioseal Inc.	19736/25	FDA UDI	Class I	Active
Bioseal Inc.	1143/25	FDA UDI	Class I	Active
Bioseal Inc.	19115NS/50	FDA UDI	Class I	Active
Bioseal Inc.	4916/20	FDA UDI	Class I	Active
Bioseal Inc.	25-711NS/20	FDA UDI	Class I	Active
Bioseal Inc.	17318/20	FDA UDI	Class I	Active
Bioseal Inc.	463-026-PK/20	FDA UDI	Class I	Active
Bioseal Inc.	11-176 BK/20	FDA UDI	Class I	Active
Bioseal Inc.	111-03/20	FDA UDI	Class I	Active
Bioseal Inc.	3164RG/24	FDA UDI	Class I	Active
Bioseal Inc.	17177/20	FDA UDI	Class I	Active
Bioseal Inc.	17634/10	FDA UDI	Class I	Active
Bioseal Inc.	17176/10	FDA UDI	Class I	Active
Bioseal Inc.	19652/20	FDA UDI	Class I	Active
Bioseal Inc.	27-778B/20	FDA UDI	Class I	Active
Bioseal Inc.	19739/20	FDA UDI	Class I	Active
Bioseal Inc.	17529/50	FDA UDI	Class I	Active
Bioseal Inc.	28854CS/10	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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Authorities

Not available yet.

FDA Recalls (5)

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
Mar 23, 2021	Z-1624-2021	—	completed	Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
Mar 23, 2021	Z-1623-2021	—	completed	Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
Mar 23, 2021	Z-1622-2021	—	completed	Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity.
Aug 15, 2019	Z-2795-2020	—	terminated	The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size and pose a serious heath risk to patient.
Oct 18, 2017	Z-0085-2018	—	completed	Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.