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: CORE1/REBORN Implant Fixture
EUDAMEDClass IIb (EU MDR)
Ref : CORE1/REBORN Implant
Identity
- Trade Name
- : CORE1/REBORN Implant Fixture EUDAMED
- Device Name
- CORE1/REBORN Implant - Fixture EUDAMED
- Model / Reference
- : CORE1/REBORN Implant EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800023156287 EUDAMED
- Basic UDI-DI
- 88000231CORREBORNIMM5 EUDAMED
- Direct Marketing DI
- 08800023156287 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
: CORE1/REBORN Implant Fixture by Cybermed Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88000231CORREBORNIMM5 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Cybermed Inc.,
- EUDAMED SRN
- KR-MF-000009356
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 16f6cf0a-5beb-4ebc-8174-1ef7083e26c8 61 fields · synced Jul 29, 2026