Identity
- Trade Name
- Ai-Motor (EDGEAPEX HP) EUDAMEDWOODPECKER FDA UDI
- Generic Name
- Dental power tool system handpiece, remotely-driven FDA UDI
- Device Name
- Endo Motor and Apex Locator Unit/Endo Motor EUDAMEDDental power tool system handpiece, remotely-driven FDA UDI
- Model / Reference
- Z1211 EUDAMEDAi-Motor FDA UDI
- Description
- Dental power tool system handpiece, remotely-driven FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944843603537 EUDAMEDFDA UDI
- Basic UDI-DI
- 694484360018K9 EUDAMED
- 510(k) Number
- K203320 FDA UDI
- FDA Product Code
- EKX FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Dental power tool system handpiece, remotely-driven FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental delivery system
Ai-Motor (EDGEAPEX HP) by Guilin Woodpecker Medical Instrument Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
Similar devices
Also classified as Dental delivery system.
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- A5 SINGLE CART — CEFLA s.c. · Class IIa
- Forest — Ls Enterprises, Inc. · Class I
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 | 694484360018K9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Guilin Woodpecker Medical Instrument Co., Ltd.
- EUDAMED SRN
- CN-MF-000009139
- Authorised Representative
- MedNet EC-REP C IIb GmbH DE-AR-000011194
Sources (2)
- EUDAMED d44edd51-6919-466b-8091-4693a2cb733b 61 fields · synced Aug 4, 2026
- FDA UDI 92201fc0-bb02-4922-8973-fe3c14bb6948 34 fields · synced May 30, 2026