Identity
- Trade Name
- SurgiMend® EUDAMEDFDA UDI
- Generic Name
- Extra-gynaecological surgical mesh, collagen, non-bioabsorbable FDA UDI
- Device Name
- Collagen Matrix for Soft Tissue Reconstruction EUDAMEDSurgiMend® 25 cm x 40 cm FDA UDI
- Model / Reference
- 606-904-106 EUDAMED606-300-016 FDA UDI
- Description
- SurgiMend® 25 cm x 40 cm FDA UDI
Identifiers
- Catalog Number
- 606-300-016 FDA UDI
- Primary DI / UDI-DI
- 10381780357261 EUDAMED10381780113126 FDA UDI
- Basic UDI-DI
- B-10381780357261 EUDAMED
- 510(k) Number
- K083898 FDA UDI
- FDA Product Code
- FTM FDA UDI
- EMDN Code
- P900299 SURGICAL MESHES - OTHER EUDAMED
- GMDN Term
- Extra-gynaecological surgical mesh, collagen, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3300 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
Yes
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Extra-gynaecological surgical mesh, collagen, non-bioabsorbable
SurgiMend® by Tei Biosciences Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Extra-gynaecological surgical mesh, collagen, non-bioabsorbable.
- Integra® — Integra Lifesciences Corp. · Class II
- Integra® — Integra Lifesciences Corp. · Class II
- SurgiMend® — TEI BIOSCIENCES INC. · Class II
- SurgiMend® — TEI BIOSCIENCES INC. · Class II
- SurgiMend® — TEI BIOSCIENCES INC. · Class II
- SurgiMend® — TEI BIOSCIENCES INC. · Class II
- SurgiMend® — TEI BIOSCIENCES INC. · Class II
- SurgiMend® — TEI BIOSCIENCES INC. · Class II
Cleared under the same submission
K083898 also covers:
- SurgiMend® — TEI BIOSCIENCES INC.
- SurgiMend® — TEI BIOSCIENCES INC.
- SurgiMend® — TEI BIOSCIENCES INC.
- SurgiMend® — TEI BIOSCIENCES INC.
- SurgiMend® — TEI BIOSCIENCES INC.
- SurgiMend® — TEI BIOSCIENCES INC.
- SurgiMend® — TEI BIOSCIENCES INC.
- SurgiMend® — TEI BIOSCIENCES INC.
- SurgiMend® — TEI BIOSCIENCES INC.
- SurgiMend® — TEI BIOSCIENCES INC.
- SurgiMend® — TEI BIOSCIENCES INC.
- SurgiMend® — TEI BIOSCIENCES INC.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tei Biosciences Inc.
Sources (2)
- FDA UDI 357b2dee-8c5c-4497-bf89-1d6a7dd47073 38 fields · synced Sep 17, 2026
- EUDAMED cc719499-2ea5-4401-9dec-6f143d1586b2 61 fields · synced Sep 17, 2026