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HAT 1 Scanning Kit
EUDAMEDClass I (EU MDR)
Ref PKA-17Model 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
Identity
- Trade Name
- HAT 1 Scanning Kit 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 EUDAMEDPKA-17 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975136231175 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 Scanning Kit 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 |
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Manufacturer
- Manufacturer
- Ziyang Freqty Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000019421
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 070a3ed2-e7f4-41d5-b8da-ecec787d06b8 61 fields · synced Oct 5, 2026