← Back to catalogue
Champy Bone Biopsy Instrument Set Consisting of Trocar, a Toothed Trephine And …
EUDAMEDClass I (EU MDR)
Ref OR-022-00
Identity
- Trade Name
- Champy Bone Biopsy Instrument Set Consisting of Trocar, a Toothed Trephine And a Plunger Reamer 22 cm - 8 1/2" Stainless Steel EUDAMED
- Device Name
- Cutting Instruments EUDAMED
- Model / Reference
- OR-022-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056111337967 EUDAMED
- Basic UDI-DI
- 50554459CUTTINGINSTRL2 EUDAMED
- EMDN Code
- L090902 ORTHOPAEDIC SURGERY TREPHINES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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: Bone trephine, reusable
Champy Bone Biopsy Instrument Set Consisting of Trocar, a Toothed Trephine And … by Surtex Instruments Ltd — Class I — MDR — listed in EUDAMED
Similar devices
Also classified as Bone trephine, reusable.
- Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Integra® Jarit® — Integra LifeSciences Production Corporation · Class II
- DENTECH — Dentech Corp. · Class I
- Karl Schumacher — KARL SCHUMACHER DENTAL, LLC · Class I
- ZOLL-DENTAL — Zoll-Dental · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
- V. Mueller — STERIS CORPORATION · 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 | 50554459CUTTINGINSTRL2 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Surtex Instruments Ltd
- EUDAMED SRN
- GB-MF-000023183
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED b77941d9-d464-437a-a032-fa0a65f18d7a 61 fields · synced Oct 6, 2026