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OnePiece Prosthetic Torque Ratchet 35 Ncm
EUDAMEDClass I (EU MDR)
Ref RA1035Model Ratchet
Identity
- Trade Name
- OnePiece Prosthetic Torque Ratchet 35 Ncm EUDAMED
- Model / Reference
- Ratchet EUDAMEDRA1035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290116777672 EUDAMED
- Basic UDI-DI
- 729011677OnePiecRatchetRE EUDAMED
- EMDN Code
- Q010280 PROSTHETIC DENTISTRY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
OnePiece Prosthetic Torque Ratchet 35 Ncm by Adin Dental Implant Systems Ltd. — Class I — 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 | 729011677OnePiecRatchetRE | Class I | Active |
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Manufacturer
- Manufacturer
- Adin Dental Implant Systems LTD.
- EUDAMED SRN
- IL-MF-000014625
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED 1e2e2bd1-ac05-440d-8a68-a926deec488d 61 fields · synced Jul 14, 2026