Identity
- Model / Reference
- MDA0000277 EUDAMEDUBS-RD50C2-07 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04589551366613 EUDAMED
- Basic UDI-DI
- 45602249800002777W EUDAMED
- EMDN Code
- V0199 CUTTING DEVICES, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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: Cranial bur, single-use
Ubs-Rd50c2-07 by Nakanishi Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Cranial bur, single-use.
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- J-Notch Burs — Stryker Instruments · Class IIa
- Bone cutters — WILSON (Shanghai) Medical Device Co., Ltd. · Class IIa
- GT PODO 5 mm rund/round Schaft 2, 35 x 35 — LUKAS-ERZETT GmbH & Co.KG · Class I
- PMT Drill Cutter — adeor Medical AG · Class II
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 | 45602249800002777W | Class IIa | Active |
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Manufacturer
- Manufacturer
- Nakanishi Inc.
- EUDAMED SRN
- JP-MF-000011271
- Authorised Representative
- NSK Europe GmbH DE-AR-000007040
Sources (1)
- EUDAMED 97ab1d41-a5b8-4347-a47a-1765d6924d7e 61 fields · synced Jul 9, 2026