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Metoofill+ Volume
EUDAMEDClass III (EU MDR)
Ref BPLN2-60BCRef BPLN-60JCRef BPLN2-60JCRef BPLN4-60JCRef BPLN-60Ref BPLN4-60BC
Identity
- Trade Name
- METOOFILL+ VOLUME EUDAMED
- Device Name
- METOOFILL+ VOLUME EUDAMED
- Model / Reference
- BPLN2-60BC EUDAMEDBPLN-60JC EUDAMEDBPLN2-60JC EUDAMEDBPLN4-60JC EUDAMEDBPLN-60 EUDAMEDBPLN4-60BC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809639785812 EUDAMED08809639784815 EUDAMED08809639785478 EUDAMED08809639786147 EUDAMED08809639784488 EUDAMED08809639786482 EUDAMED
- Basic UDI-DI
- B-08809639785812 EUDAMEDB-08809639784815 EUDAMEDB-08809639785478 EUDAMEDB-08809639786147 EUDAMEDB-08809639784488 EUDAMEDB-08809639786482 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
Metoofill+ Volume 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-08809639785812 | Class III | Active |
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Manufacturer
- Manufacturer
- BioPlus Co., Ltd.
- EUDAMED SRN
- KR-MF-000008618
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (6)
- EUDAMED 0033cb6d-17c5-4c82-b2c3-2734a78c3a11 61 fields · synced Jul 21, 2026
- EUDAMED 831a42e1-ffb6-4e7f-82a3-f38d9db9c671 61 fields · synced May 16, 2026
- EUDAMED 8305ee7c-624f-4c49-b96d-05c3e403840b 61 fields · synced May 17, 2026
- EUDAMED 149d86ee-a0e2-4182-bc66-49d931410651 61 fields · synced May 18, 2026
- EUDAMED cc0a4402-ba88-470f-8dd8-b849c21ae6e9 61 fields · synced May 18, 2026
- EUDAMED b8e6cb72-9114-4002-b3cd-ca2c304e9ed3 61 fields · synced May 18, 2026