Identity
- Trade Name
- Dpex X EUDAMEDDTE FDA UDI
- Generic Name
- Endodontic apex locator FDA UDI
- Device Name
- Apex Locator EUDAMEDFDA UDI
- Model / Reference
- Z1211 EUDAMEDDpex X FDA UDI
- Description
- Apex Locator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944843658759 EUDAMEDFDA UDI
- Basic UDI-DI
- 694484360080KE EUDAMED
- 510(k) Number
- K181087 FDA UDI
- FDA Product Code
- LQY FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Endodontic apex locator FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU 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
No
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
Dpex X by Guilin Woodpecker Medical Instrument Co., Ltd. — Class IIa — 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 | 694484360080KE | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
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 72715203-a907-4264-9a17-37f1d4a1fd09 61 fields · synced Oct 6, 2026
- FDA UDI 8cd23e18-b987-48bf-bdea-9f8f46f9a5a4 34 fields · synced May 30, 2026