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VariAX 2 Xpress Distal Radius Kit
EUDAMEDClass IIa (EU MDR)
Ref 991065SModel 220-TXTS-006 (485661028)
Identity
- Trade Name
- VariAX 2 Xpress Distal Radius Kit EUDAMED
- Device Name
- Oasys Audible Torque Wrench EUDAMED
- Model / Reference
- 220-TXTS-006 (485661028) EUDAMED991065S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00857676008225 EUDAMED
- Basic UDI-DI
- 0857676008RA958572 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
VariAX 2 Xpress Distal Radius Kit 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 | 0857676008RA958572 | 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 f8a5e4cb-99d4-451a-91ae-57e65a37c5da 61 fields · synced Jul 10, 2026