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Epi-Guide Bioresorbable Barrier Matrix
EUDAMEDFDA UDIClass III (EU MDR)
Ref 50600-03Model EG00050
Identity
- Trade Name
- Epi-Guide Bioresorbable Barrier Matrix EUDAMEDEpiGuide® Bioresorbable Barrier Matrix FDA UDI
- Generic Name
- Pliable-polymer dental regeneration membrane, bioabsorbable, tacked FDA UDI
- Device Name
- Epi-Guide EUDAMED
- Model / Reference
- EG00050 EUDAMED50600-03 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 50600-03 FDA UDI
- Primary DI / UDI-DI
- 00812337027144 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00812337027144 EUDAMED
- 510(k) Number
- K940643 FDA UDI
- FDA Product Code
- LYC FDA UDI
- EMDN Code
- Q010301 PERIODONTAL MEMBRANES EUDAMED
- GMDN Term
- Pliable-polymer dental regeneration membrane, bioabsorbable, tacked FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3930 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
No
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
Dimensions & Sizes
- Size
- Length — 30 Millimeter FDA UDIWidth — 18 Millimeter FDA UDI
Epi-Guide Bioresorbable Barrier Matrix by Dsm Biomedical, Inc. — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00812337027144 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- DSM Biomedical, Inc.
- EUDAMED SRN
- US-MF-000021393
- Authorised Representative
- DSM Biomedical B.V. NL-AR-000018633
Sources (2)
- EUDAMED b7a9f2a1-958e-4319-af27-5e1570c1854d 61 fields · synced Jul 17, 2026
- FDA UDI 481fd243-7f76-4a31-b5a8-48d174326c72 35 fields · synced May 30, 2026