← Back to catalogue
Drilling Guide
EUDAMEDClass I (EU MDR)
Ref OTAGP001Ref GDP40-35/3.5Model Class Ir Instrument
Identity
- Trade Name
- DRILLING GUIDE EUDAMEDDRILLING GUIDE BIG SECTION EUDAMED
- Device Name
- Class Ir Instrument EUDAMED
- Model / Reference
- OTAGP001 EUDAMEDClass Ir Instrument EUDAMEDGDP40-35/3.5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483OTAGP0010 EUDAMED+M483GDP4035350 EUDAMED
- Basic UDI-DI
- ++M483L0911YN EUDAMED
- Direct Marketing DI
- +M483OTAGP0010 EUDAMED+M483GDP4035350 EUDAMED
- EMDN Code
- L091002 INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE EUDAMED
Classification
- Device Class
- Class I 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: Wire holding/twisting forceps
Drilling Guide by groupe lépine — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Wire holding/twisting forceps.
- WAVY FRENCH BENDER — ETABLISSEMENTS OURY GUYE ET FILS · Class I
- ROCCIA MultiLIF, ALIF, TLIF — SILONY MEDICAL GMBH · Class I
- Raszpla — ChM spółka z ograniczoną odpowiedzialnością · Class I
- Preparator — ChM spółka z ograniczoną odpowiedzialnością · Class I
- Retraktor — ChM spółka z ograniczoną odpowiedzialnością · Class I
- Trokar — ChM spółka z ograniczoną odpowiedzialnością · Class I
- SYMPHONY OCT SYSTEM — MEDOS INTERNATIONAL SARL · Class I
- McGee wire closing forceps, comfort — Spiggle & Theis Medizintechnik GmbH · 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 | ++M483L0911YN | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- groupe lépine
- EUDAMED SRN
- FR-MF-000001182
Sources (2)
- EUDAMED 90202df1-462c-47d2-af22-1a8a9c1132ab 61 fields · synced Aug 1, 2026
- EUDAMED abf136d7-44e6-4f95-9a56-d07ba62cd826 61 fields · synced May 18, 2026