Identity
- Trade Name
- PT-A EUDAMEDWOODPECKER FDA UDI
- Generic Name
- Ultrasonic dental scaling/debridement system FDA UDI
- Device Name
- Dental Scaler and Air Polisher EUDAMEDUltrasonic dental scaling/debridement system FDA UDI
- Model / Reference
- Z121101 EUDAMEDPT-A FDA UDI
- Description
- Ultrasonic dental scaling/debridement system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944843604626 EUDAMEDFDA UDI
- Basic UDI-DI
- 694484360008K6 EUDAMED
- 510(k) Number
- K053555 FDA UDI
- FDA Product Code
- ELC FDA UDI
- EMDN Code
- Z12110101 DENTAL TREATMENT UNITS EUDAMED
- GMDN Term
- Ultrasonic dental scaling/debridement system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.4850 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental delivery system
Pt-A 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 | 694484360008K6 | 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 cea24171-c802-47f2-af17-ba877be0fe48 61 fields · synced Jul 10, 2026
- FDA UDI cdbcf41d-5cd1-4fe1-a933-b222d388560f 34 fields · synced May 30, 2026