Identity
- Trade Name
- Calibration Bur FDA UDI
- Generic Name
- Surgical power tool system control unit, line-powered FDA UDI
- Model / Reference
- MDA0000028 EUDAMEDZ1057101 EUDAMEDCalibration Bur FDA UDI
Identifiers
- Catalog Number
- Z1057101 FDA UDI
- Primary DI / UDI-DI
- 04560264575134 EUDAMED04589551381449 FDA UDI
- Basic UDI-DI
- 456022498000002877 EUDAMED
- FDA Product Code
- EBW FDA UDI
- EMDN Code
- Z12110180 INSTRUMENTS FOR DENTAL TREATMENT UNITS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Surgical power tool system control unit, line-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Z1057101 by Nakanishi Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 456022498000002877 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Nakanishi Inc.
- EUDAMED SRN
- JP-MF-000011271
- Authorised Representative
- NSK Europe GmbH DE-AR-000007040
Sources (2)
- EUDAMED 317fff17-ff57-417c-a321-5c9d14cc9966 61 fields · synced Jul 9, 2026
- FDA UDI 2a883b6d-bff9-424e-810e-68a0b2a0d39f 33 fields · synced May 25, 2026