← Back to catalogue
HAT 1 Scanbody
EUDAMEDClass I (EU MDR)
Ref PS-01Model HAT 1 Scanbody: PS-01~07; HAT 1 Lab Analog: PA-01~02; HAT 1 Screwdriver: PD-S-01~02, PD-A-01~07; HAT 1 Scanning Kit: PKA-01~27Ref PS-02Ref PS-07Ref PS-03
Identity
- Trade Name
- HAT 1 Scanbody EUDAMED
- Device Name
- Dental implant accessories EUDAMED
- Model / Reference
- HAT 1 Scanbody: PS-01~07; HAT 1 Lab Analog: PA-01~02; HAT 1 Screwdriver: PD-S-01~02, PD-A-01~07; HAT 1 Scanning Kit: PKA-01~27 EUDAMEDPS-01 EUDAMEDPS-02 EUDAMEDPS-07 EUDAMEDPS-03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975136232011 EUDAMED06975136232028 EUDAMED06975136232073 EUDAMED06975136232035 EUDAMED
- Basic UDI-DI
- 697513623PTHAT1RS EUDAMED
- EMDN Code
- P01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
HAT 1 Scanbody by Ziyang Freqty Medical Equipment Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697513623PTHAT1RS | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ziyang Freqty Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000019421
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (4)
- EUDAMED a639e430-8b06-48e9-b87d-3b0bc6441653 61 fields · synced Oct 6, 2026
- EUDAMED ac33acc9-2d54-4f52-8fe1-74b5a9fcd1ce 61 fields · synced May 17, 2026
- EUDAMED d47498e5-9d7e-41e7-9280-4f8d1c243d99 61 fields · synced May 17, 2026
- EUDAMED 0a02a783-aef5-48c1-843d-35b3eca3afff 61 fields · synced May 18, 2026