← Back to catalogue
Trial Head 36 +8
EUDAMEDClass IIa (EU MDR)
Ref HTA CX436Model Orthopaedic prostheses positioners, reusable
Identity
- Trade Name
- TRIAL HEAD 36 +8 EUDAMED
- Device Name
- Orthopaedic prostheses positioners, reusable EUDAMED
- Model / Reference
- Orthopaedic prostheses positioners, reusable EUDAMEDHTA CX436 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483HTACX4360 EUDAMED
- Basic UDI-DI
- ++M483L091104F9 EUDAMED
- Direct Marketing DI
- +M483HTACX4360 EUDAMED
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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: Orthopaedic implant impactor, reusable
Trial Head 36 +8 by groupe lépine — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic implant impactor, reusable.
- MobiliT Cup — CORIN LTD · Class II
- R3 — Smith & Nephew, Inc. · Class II
- MobiliT Cup — CORIN LTD · Class II
- KMEDIC — TELEFLEX INCORPORATED · Class I
- R3 — Smith & Nephew, Inc. · Class I
- Head Impactor — Metrimed Orvosi Műszergyártó Kft. · Class I
- Integra® — Ascension Orthopedics, Inc. · Class I
- R3 — Smith & Nephew, Inc. · 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 | ++M483L091104F9 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- groupe lépine
- EUDAMED SRN
- FR-MF-000001182
Sources (1)
- EUDAMED 590639b2-198b-46ce-abcf-e25ab2e4629a 61 fields · synced Jun 18, 2026