Identity
- Trade Name
- KBIO® Dura EUDAMEDFDA UDI
- Generic Name
- Dura mater biomatrix implant FDA UDI
- Device Name
- Collagen Dural Regeneration Matrix EUDAMEDDural Repair Collagen Matrix 50 x 50 50 x 50mm (2 x 2in) FDA UDIDural Repair Collagen Matrix 125 x 175 125 x 175mm (5 x 7in) FDA UDI
- Model / Reference
- KBI-DU 05 07-S EUDAMEDFDA UDIKBI-DU 02 02-S FDA UDI
- Description
- Dural Repair Collagen Matrix 50 x 50 50 x 50mm (2 x 2in) FDA UDIDural Repair Collagen Matrix 125 x 175 125 x 175mm (5 x 7in) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00813954023823 EUDAMEDFDA UDI00813954023793 FDA UDI
- Basic UDI-DI
- B-00813954023823 EUDAMED
- FDA Product Code
- GXQ FDA UDI
- EMDN Code
- N018099 ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Dura mater biomatrix implant FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 882.5910 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Width — 50 Millimeter FDA UDILength — 50 Millimeter FDA UDIWidth — 125 Millimeter FDA UDILength — 175 Millimeter FDA UDI
Category: Dura mater biomatrix implant
KBIO® Dura by Collagen Matrix, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dura mater biomatrix implant.
- DuraGen® Plus — Integra Lifesciences Corp. · Class II
- DuraGen® Secure — Integra Lifesciences Corp. · Class II
- DuraGen® — Integra Lifesciences Corp. · Class II
- DURAFORM — Cerenovus, Inc. · Class II
- DURASIS — COOK BIOTECH INCORPORATED · Class II
- Biodesign — COOK BIOTECH INCORPORATED · Class II
- DURAFORM — Natus Medical Incorporated · Class II
- DuraGen® Suturable — Integra Lifesciences Corp. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
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
- Collagen Matrix, Inc.
Sources (3)
- FDA UDI 0851155a-5306-477d-a53f-b1284e7744ed 34 fields · synced Jul 8, 2026
- FDA UDI 1240d52d-ce23-4ea5-a771-73d5b028b37e 34 fields · synced May 30, 2026
- EUDAMED 8414fd53-30e6-481b-aeb3-d236ab293962 61 fields · synced Jul 8, 2026