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TEI BIOSCIENCES INC.

United States·US-MF-000012766

Last updated May 27, 2026

Information

Country: United States
Address: 7, Elkins Street, Boston, MA, United States
Website: integralife.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 8572054033
PRRC Contact: Waqar Zaidi
EUDAMED SRN: US-MF-000012766
FDA FEI Number: —
DUNS Number: 796253292

Catalogue (159)

Page 3 of 4

Device	Model / Reference	Registries	Class	Status
SurgiMend®	606-304-002	FDA UDI	Class II	Active
SurgiMend®	606-002-002	FDA UDI	Class II	Active
SurgiMend®	606-400-017	FDA UDI	Class II	Active
SurgiMend®	606-300-009	FDA UDI	Class II	Active
PriMatrix®	607-004-880	FDA UDI	U	Active
PriMatrix®	607-004-225	FDA UDI	U	Unknown
SurgiMend®	606-001-005	FDA UDI	Class II	Active
SurgiMend®	606-005-003	FDA UDI	Class II	Active
PriMatrix Ag	607-101-125	FDA UDI	U	Active
SurgiMend®	606-200-009	FDA UDI	Class II	Active
SurgiMend®	606-001-007	FDA UDI	Class II	Active
SurgiMend®	606-004-100	FDA UDI	Class II	Active
SurgiMend®	606-404-001	FDA UDI	Class II	Active
PriMatrix® Ag	607-105-812	FDA UDI	U	Active
PriMatrix® Ag	607-105-125	FDA UDI	U	Unknown
RevizeTM-X	611-005-002	FDA UDI	Class II	Active
SurgiMend®	606-206-006	FDA UDI	Class II	Active
SurgiMend®	606-300-017	FDA UDI	Class II	Active
SurgiMend®	606-300-020	FDA UDI	Class II	Active
TissueMend®	6495-9-001	FDA UDI	Class II	Active
SurgiMend®	606-004-106	FDA UDI	Class II	Active
PriMatrix Ag	607-101-880	FDA UDI	U	Active
PriMatrix Ag	607-101-440	FDA UDI	U	Active
PriMatrix®	6495-9-114	FDA UDI	U	Unknown
SurgiMend®	606-004-110	FDA UDI	Class II	Active
SurgiMend®	606-403-001	FDA UDI	Class II	Active
SurgiMend®	606-001-010	FDA UDI	Class II	Active
PriMatrix® Ag	607-104-225	FDA UDI	U	Active
SurgiMend®	606-004-107	FDA UDI	Class II	Active
PriMatrix®	607-005-220	FDA UDI	U	Active
SurgiMend®	606-206-002	FDA UDI	Class II	Active
PriMatrix®	607-005-225	FDA UDI	U	Active
PriMatrix® Ag	607-105-112	FDA UDI	U	Active
SurgiMend®	606-003-002	FDA UDI	Class II	Active
SurgiMend®	606-005-002	FDA UDI	Class II	Active
PriMatrix Ag	607-101-812	FDA UDI	U	Active
SurgiMend®	606-004-102	FDA UDI	Class II	Active
PriMatrix® Ag	607-105-225	FDA UDI	U	Unknown
PriMatrix®	607-001-660	FDA UDI	U	Active
SurgiMend®	606-001-009	FDA UDI	Class II	Active
SurgiMend®	606-200-016	FDA UDI	Class II	Active
SurgiMend®	606-300-016	EUDAMEDFDA UDI	Class II	Active
Durepair™	62110	FDA UDI	Class II	Active
Tissuemend Soft Tissue Repair Matrix	K060989	FDA 510(k)	Class II	Active
Cosmatrix	K060829	FDA 510(k)	Class II	Active
Primatrix Dermal Repair Scaffold	K131286	FDA 510(k)	U	Active
Orthomend	K051766	FDA 510(k)	Class II	Active
Primatrix Dermal Repair Scaffold	K083440	FDA 510(k)	U	Active
Xenform Soft Tissue Repair Matrix	K060984	FDA 510(k)	Class II	Active
Tissuemend Soft Tissue Repair Matrix	K020455	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (18)

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
May 23, 2023	Z-2075-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2085-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2072-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2080-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2069-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2079-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2071-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2078-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2083-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2073-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2084-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2070-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2076-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2081-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2077-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2074-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
May 23, 2023	Z-2082-2023	—	open, classified	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
Jun 15, 2017	Z-0383-2018	—	terminated	During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages: " 22 IFUs contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50 " 3 IFUs were missing pages 27 - 50 " 1 IFU was missing pages 1 - 2 & 75 - 76 " 1 IFU was missing pages 15 - 62 While pages 27 50, 75 76, and 15 62 contain instructions written in a language other than English, pages 1 2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device.