TruTORQ Large Engine Adaptor, 12 Nm
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- TruTORQ Large Engine Adaptor, 12 Nm EUDAMEDTruTorq Adaptor Sterile, Single Use FDA UDI
- Generic Name
- Surgical torque wrench, single-use FDA UDI
- Device Name
- TruTORQ Single use Torque Limiting Instruments EUDAMED
- Model / Reference
- 801-XXX EUDAMED803-002 EUDAMED12 Nm FDA UDI
Identifiers
- Catalog Number
- 803-002 FDA UDI
- Primary DI / UDI-DI
- 00857676008287 EUDAMEDFDA UDI
- Basic UDI-DI
- 0857676008RA958776 EUDAMED
- EMDN Code
- P091399 ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Surgical torque wrench, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Joint prosthesis implantation kit, single-use
TruTORQ Large Engine Adaptor, 12 Nm by Eca Medical Instruments — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0857676008RA958776 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Eca Medical Instruments
- EUDAMED SRN
- US-MF-000010686
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED be5029be-9a70-4dca-8d27-227ad1aa4aec 61 fields · synced Jul 17, 2026
- FDA UDI 46b30e8d-f4d9-4dca-97e3-27b8cb7992b3 33 fields · synced May 24, 2026