Identity
- Trade Name
- Dental Electric Motor EUDAMEDWOODPECKER FDA UDI
- Generic Name
- Dental delivery system instrument unit, electric FDA UDI
- Device Name
- Dental Electric Motor EUDAMEDDental delivery system instrument unit, electric FDA UDI
- Model / Reference
- MT20201 EUDAMEDMT2 FDA UDI
- Description
- Dental delivery system instrument unit, electric FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944843605173 EUDAMEDFDA UDI
- Basic UDI-DI
- 694484360517KY EUDAMED
- 510(k) Number
- K203706 FDA UDI
- FDA Product Code
- EGS FDA UDIEBW FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Dental delivery system instrument unit, electric FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental delivery system
Dental Electric Motor by Guilin Woodpecker Medical Instrument Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203706 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 694484360517KY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Guilin Woodpecker Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000009139
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (3)
- EUDAMED c15184c5-1955-43fa-b9d9-4f1043403e34 61 fields · synced Jul 30, 2026
- FDA UDI d9b9d622-cf5f-4ced-9ed7-aa8dbcd15ac6 34 fields · synced May 29, 2026
- FDA 510(k) K203706 1 fields · synced May 18, 2026