Identity
- Trade Name
- Revite INTENSILO H EUDAMED
- Device Name
- Revite INTENSILO H EUDAMED
- Model / Reference
- BPL100-60C EUDAMEDBPL100-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947981722 EUDAMED08809947981852 EUDAMED
- Basic UDI-DI
- B-08809947981722 EUDAMEDB-08809947981852 EUDAMED
- EMDN Code
- P900402 RESORBABLE FILLING AND RECONSTRUCTION DEVICES EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Revite INTENSILO H by BioPlus Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809947981722 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BioPlus Co., Ltd.
- EUDAMED SRN
- KR-MF-000008618
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED de5ae66f-542a-4157-96fc-9662a0aae952 61 fields · synced Jul 12, 2026
- EUDAMED 8eea8a46-654e-47c1-b89b-04b1125d20c4 61 fields · synced May 17, 2026