← Back to catalogue
Borchardt Twist Drill 5 mm Borchardt Shaft, Long Working End Ø 5.0 mm Stainless…
EUDAMEDClass I (EU MDR)
Ref OR-060-50Ref OR-060-40Ref OR-060-30Ref OR-060-35Ref OR-060-25
Identity
- Trade Name
- Borchardt Twist Drill 5 mm Borchardt Shaft, Long Working End Ø 5.0 mm Stainless Steel EUDAMEDBorchardt Twist Drill 5 mm Borchardt Shaft, Long Working End Ø 4.0 mm Stainless Steel EUDAMEDBorchardt Twist Drill 5 mm Borchardt Shaft, Long Working End Ø 3.0 mm Stainless Steel EUDAMEDBorchardt Twist Drill 5 mm Borchardt Shaft, Long Working End Ø 3.5 mm Stainless Steel EUDAMEDBorchardt Twist Drill 5 mm Borchardt Shaft, Long Working End Ø 2.5 mm Stainless Steel EUDAMED
- Device Name
- Cutting Instruments EUDAMED
- Model / Reference
- OR-060-50 EUDAMEDOR-060-40 EUDAMEDOR-060-30 EUDAMEDOR-060-35 EUDAMEDOR-060-25 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055445936747 EUDAMED05055445936730 EUDAMED05055445936709 EUDAMED05055445936723 EUDAMED05055445936693 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
Borchardt Twist Drill 5 mm Borchardt Shaft, Long Working End Ø 5.0 mm Stainless… 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 (5)
- EUDAMED 6787a9f8-c2d3-4a63-abc0-892590d1bd66 61 fields · synced Jul 23, 2026
- EUDAMED 3a587f3e-217b-47cb-adb1-4fdb527ecce1 61 fields · synced May 16, 2026
- EUDAMED d1d68d26-5ac3-4779-95b8-e7eae74ccd9f 61 fields · synced May 16, 2026
- EUDAMED d5aebe42-9659-468f-8e93-9edd02de96e2 61 fields · synced May 18, 2026
- EUDAMED 921fccd3-6199-43df-9b20-8a91a1a6f5ac 61 fields · synced May 18, 2026