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UF(II) Hybrid Link
EUDAMEDClass IIb (EU MDR)
Ref DIO Implant System Product Catalog Ver 7.0 (KR)Model 2HAA 451515AH
Identity
- Trade Name
- UF(II) Hybrid Link EUDAMED
- Device Name
- UF(II) 2-Channel Abutment, UF(II) Narrow Hybrid Link, UF(II) Hybrid Link, UF(II) Narrow DeSR Base Abutment, UF(II) DeSR Base Abutment, UF(II) Narrow DeSR Healing Cap, UF(II) DeSR Healing Cap, UF(II) 2-Channel Abutment Screw, and 4 additional items EUDAMED
- Model / Reference
- 2HAA 451515AH EUDAMEDDIO Implant System Product Catalog Ver 7.0 (KR) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800049278369 EUDAMED
- Basic UDI-DI
- 880004925005B8 EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
UF(II) Hybrid Link by DIO Corporation — 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 | 880004925005B8 | Class IIb | Active |
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Manufacturer
- Manufacturer
- DIO Corporation
- EUDAMED SRN
- KR-MF-000008515
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED c704c6d9-6b21-4cd7-b626-c73f5e149333 61 fields · synced Aug 1, 2026