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Implant driver, handpiece, L, R.
EUDAMEDClass IIa (EU MDR)
Ref ITHLModel Implant drivers, handpiece
by Trate Ag
Identity
- Trade Name
- Implant driver, handpiece, L, R. EUDAMED
- Model / Reference
- Implant drivers, handpiece EUDAMEDITHL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 37630053808915 EUDAMED
- Basic UDI-DI
- 76300538ImplantdriverHN6 EUDAMED
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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: Surgical retraction system, reusable
Implant driver, handpiece, L, R. by Trate Ag — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical retraction system, reusable.
- 45930R — Thompson Surgical Instruments, Inc. · Class IIa
- Sigma — ALPHATEC SPINE, INC. · Class I
- Omni-Tract® — Integra Lifesciences Corp. · Class I
- Drills and Handpieces — SOUTHERN IMPLANTS (PTY) LTD · Class IIa
- Thompson — Thompson Surgical Instruments · Class I
- Nordent Manufacturing, Inc. — NORDENT MANUFACTURING INC · Class I
- Thompson — Thompson Surgical Instruments · Class I
- Thompson — Thompson Surgical Instruments · Class I
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 | 76300538ImplantdriverHN6 | Class IIa | Active |
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Manufacturer
Sources (1)
- EUDAMED 54f92e31-49cd-44c7-bafd-0f9bdc6cfb9b 61 fields · synced Jun 19, 2026