← Back to catalogue
Orthopaedic Osteotomes
EUDAMEDClass I (EU MDR)
Ref 03.111.028Model Orthopaedic Osteotomes
by Synthes GmbH
Identity
- Device Name
- Orthopaedic Osteotomes EUDAMED
- Model / Reference
- Orthopaedic Osteotomes EUDAMED03.111.028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07611819375888 EUDAMED
- Basic UDI-DI
- 7611819a00073JB EUDAMED
- Direct Marketing DI
- 07611819375888 EUDAMED
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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: Bone cutting forceps, reusable
Orthopaedic Osteotomes by Synthes GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone cutting forceps, reusable.
- Acetabular Reamer 47mm — Viant Medical, LLC · Class IIa
- Gimmi — Gimmi GmbH · Class I
- GLOBAL UNITE — DePuy Ireland UC · Class I
- KNEO FEMORAL CUTTING BLOCK S08 — groupe lépine · Class I
- AG15-0002 — X.NOV MEDICAL TECHNOLOGY · Class I
- SPECIALIST 2 — DePuy Ireland UC · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Acetabular Reamer 55mm — Viant Medical, LLC · Class IIa
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 | 7611819a00073JB | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Synthes GmbH
- EUDAMED SRN
- CH-MF-000013345
- Authorised Representative
- DePuy Ireland UC IE-AR-000009328
Sources (1)
- EUDAMED 603899e8-0e84-46ee-9220-7e1a4cf39b80 61 fields · synced Jun 18, 2026