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THE Graft Collagen
EUDAMEDFDA UDIFDA 510(k)Class III (EU MDR)
Ref TCR-02510(k) K230305Ref TCB-02Ref TCB-03Ref TG-MS05Ref BG-M10Ref BG-M25Ref TCB-01Ref BG-M05Ref TCB-04Ref TG-BS25Ref BG-A15Ref TG-BS10
Identity
- Trade Name
- THE Graft Collagen EUDAMEDFDA UDITHE Graft EUDAMEDFDA UDI
- Generic Name
- Dental bone matrix implant, animal-derived FDA UDI
- Device Name
- THE Graft Collagen EUDAMEDTHE Graft EUDAMED
- Model / Reference
- TCR-02 EUDAMEDTCB-02 EUDAMEDTCB-03 EUDAMEDTG-MS05 EUDAMEDBG-M10 EUDAMEDBG-M25 EUDAMEDTCB-01 EUDAMEDFDA UDIBG-M05 EUDAMEDTCB-04 EUDAMEDFDA UDITG-BS10 EUDAMEDFDA UDITG-BS25 EUDAMEDFDA UDIBG-A15 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800039005067 EUDAMED08800039005005 EUDAMED08800039005012 EUDAMED08800039002820 EUDAMED08800039002790 EUDAMED08800039002776 EUDAMED08800039004992 EUDAMEDFDA UDI08800039002783 EUDAMED08800039005029 EUDAMEDFDA UDI08800039000291 EUDAMEDFDA UDI08800039000277 EUDAMEDFDA UDI08800039000000 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800039005067 EUDAMEDB-08800039005005 EUDAMEDB-08800039005012 EUDAMEDB-08800039002820 EUDAMEDB-08800039002790 EUDAMEDB-08800039002776 EUDAMEDB-08800039004992 EUDAMEDB-08800039002783 EUDAMEDB-08800039005029 EUDAMEDB-08800039000277 EUDAMEDB-08800039000000 EUDAMEDB-08800039000291 EUDAMED
- FDA Product Code
- NPM FDA UDI
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES EUDAMED
- GMDN Term
- Dental bone matrix implant, animal-derived FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Market of Registration
- Italy EUDAMEDFrance 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 UDIFDA UDI
THE Graft Collagen by PURGO BIOLOGICS Inc. — Class III — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230305 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-08800039005067 | Class III | Active |
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Manufacturer
- Manufacturer
- Purgo Biologics Inc.
- EUDAMED SRN
- KR-MF-000006105
- FDA Applicant
- Purgo Biologics, Inc.
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (20)
- EUDAMED 99094685-7416-4f6f-9754-eecfbc397f1f 85 fields · synced Oct 6, 2026
- EUDAMED 54fd332e-f4d0-475b-8f76-9793856aa149 61 fields · synced May 17, 2026
- EUDAMED dc7491ab-07d1-4eab-8835-986b160793cb 61 fields · synced May 17, 2026
- EUDAMED a88ce8a6-d458-4882-9686-f3361e0a4051 61 fields · synced May 17, 2026
- EUDAMED 8099753c-0e57-41a8-8add-b61a08115cba 61 fields · synced May 17, 2026
- EUDAMED 9063e394-27fe-495b-b03d-d5026deac51f 61 fields · synced May 18, 2026
- EUDAMED 6a7a6568-f30f-4bb4-88ae-46da35831a95 61 fields · synced May 18, 2026
- EUDAMED 76d9d449-9e59-4506-b375-31d4ac56969a 61 fields · synced May 18, 2026
- EUDAMED c13a5029-5a0b-4e2b-9451-572253db899b 61 fields · synced May 18, 2026
- FDA UDI a17126fa-7d99-4676-ac11-8e4a8f2ff94f 33 fields · synced May 29, 2026
- FDA UDI 61e4540b-3fd4-44cc-9ec9-61a5c4872eac 33 fields · synced May 30, 2026
- FDA UDI 795b9a42-6e12-41e7-84f2-1047431d7216 33 fields · synced May 30, 2026
- FDA UDI 82368dd0-083e-49a5-a5f7-2233b271edb0 33 fields · synced May 30, 2026
- FDA UDI 5c60d72a-5dfe-483f-9074-7ce27f70bb6d 33 fields · synced May 30, 2026
- EUDAMED 25da21fa-d473-4e2c-bcdb-37dc8d787930 61 fields · synced Jun 20, 2026
- EUDAMED 9719c3ae-7c22-42ba-806d-30406f8b45c5 61 fields · synced Jul 9, 2026
- EUDAMED a228cc66-f870-4e46-a746-5f8c7dd4e13c 61 fields · synced Jul 11, 2026
- EUDAMED c0b9827e-a8fd-4e04-bbe7-3c2592bd64a0 61 fields · synced Jul 15, 2026
- EUDAMED d6cbdb52-c5e4-45bf-a780-c457dc41885f 61 fields · synced Jul 24, 2026
- FDA 510(k) K230305 1 fields · synced May 18, 2026