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echrever INTENSE
EUDAMEDClass III (EU MDR)
Ref BPLN-60BCRef BPLN2-60JCRef BPLN2-60BCRef BPLN4-60JC
Identity
- Trade Name
- echrever INTENSE EUDAMED
- Device Name
- echrever INTENSE EUDAMED
- Model / Reference
- BPLN-60BC EUDAMEDBPLN2-60JC EUDAMEDBPLN2-60BC EUDAMEDBPLN4-60JC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809947980879 EUDAMED08809947981067 EUDAMED08809947981241 EUDAMED08809947981418 EUDAMED
- Basic UDI-DI
- B-08809947980879 EUDAMEDB-08809947981067 EUDAMEDB-08809947981241 EUDAMEDB-08809947981418 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
echrever INTENSE 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-08809947980879 | 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 (4)
- EUDAMED 74931eb6-6db6-4079-bfdb-ca7c3d94bf12 61 fields · synced Jul 22, 2026
- EUDAMED af1df6a9-8dcb-4af6-b407-1469834cfb52 61 fields · synced May 16, 2026
- EUDAMED 493379fa-16e1-4511-8be2-b58ab2eb1461 61 fields · synced May 17, 2026
- EUDAMED eac6df7e-eacc-4020-8c3a-fcd38d90d716 61 fields · synced May 18, 2026