Identity
- Trade Name
- EDGEAPEX HP EUDAMEDEDEGENDO FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, electric FDA UDI
- Device Name
- Endo Motor and Apex Locator Unit/Endo Motor EUDAMEDEDGEAPEX HP Endodontic Motor is cordless endodontic treatment motorized handpiece with root canalmeasurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. Andit can be used to enlarge the canals while monitoring the position of the file tip inside the canal. FDA UDI
- Model / Reference
- Z1211 EUDAMEDEDGEAPEX HP FDA UDI
- Description
- EDGEAPEX HP Endodontic Motor is cordless endodontic treatment motorized handpiece with root canalmeasurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. Andit can be used to enlarge the canals while monitoring the position of the file tip inside the canal. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944843619057 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 surgical power tool motorized handpiece/set, electric FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental delivery system
Edgeapex Hp by Guilin Woodpecker Medical Instrument Co., Ltd. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 af9fc3a4-9711-48b6-a879-4558ae071a5a 61 fields · synced Jul 9, 2026
- FDA UDI 5b59835f-45a4-4e9a-a20f-8dcc125e4f95 34 fields · synced May 30, 2026