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THE Cover
EUDAMEDFDA UDIClass III (EU MDR)
Ref BP5-2530Ref BP10-1520Ref BP10-2030
Identity
- Trade Name
- THE Cover EUDAMEDFDA UDI
- Generic Name
- Collagen dental regeneration membrane FDA UDI
- Device Name
- THE Cover EUDAMEDRepair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover prevents the epithelial cells from migrating to the apical end and prevents the gingival fibers from penetrating the damaged area. THE Cover induces cell proliferation from the periodontal ligament and alveolar bone FDA UDI
- Model / Reference
- BP5-2530 EUDAMEDFDA UDIBP10-1520 EUDAMEDBP10-2030 EUDAMED
- Description
- Repair or replace bone defects around teeth, increase or reconstruct alveolar bone. THE Cover prevents the epithelial cells from migrating to the apical end and prevents the gingival fibers from penetrating the damaged area. THE Cover induces cell proliferation from the periodontal ligament and alveolar bone FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800039003803 EUDAMEDFDA UDI08800039003827 EUDAMED08800039003834 EUDAMED
- Basic UDI-DI
- B-08800039003803 EUDAMEDB-08800039003827 EUDAMEDB-08800039003834 EUDAMED
- 510(k) Number
- K230091 FDA UDI
- FDA Product Code
- NPL FDA UDI
- EMDN Code
- Q010301 PERIODONTAL MEMBRANES EUDAMED
- GMDN Term
- Collagen dental regeneration membrane FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3930 FDA UDI
- Market of Registration
- Italy 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
THE Cover by PURGO BIOLOGICS 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-08800039003803 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Purgo Biologics Inc.
- EUDAMED SRN
- KR-MF-000006105
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (4)
- EUDAMED b291f2a8-f967-4795-97c5-4919b4000505 61 fields · synced Oct 6, 2026
- EUDAMED 635bb573-d126-42dd-b9df-f02ebbca7d14 61 fields · synced May 18, 2026
- EUDAMED a3baf0bb-be8e-47fe-bafb-956189b0c59d 61 fields · synced May 18, 2026
- FDA UDI f5de8c07-c889-471a-845d-17224ccb7e0e 34 fields · synced May 30, 2026