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TruTORQ Small Engine, 0.5-2.0 Nm
EUDAMEDClass IIa (EU MDR)
Ref 801-001Model 801-XXX
Identity
- Trade Name
- TruTORQ Small Engine, 0.5-2.0 Nm EUDAMED
- Device Name
- TruTORQ Single use Torque Limiting Instruments EUDAMED
- Model / Reference
- 801-XXX EUDAMED801-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00857676008317 EUDAMED
- Basic UDI-DI
- 0857676008RA958776 EUDAMED
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Joint prosthesis implantation kit, single-use
TruTORQ Small Engine, 0.5-2.0 Nm by Eca Medical Instruments — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 0857676008RA958776 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Eca Medical Instruments
- EUDAMED SRN
- US-MF-000010686
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 5349ebe5-5ed7-4b5d-8362-11a9688e1448 61 fields · synced Jun 18, 2026