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HAT 1 Scanning Kit
EUDAMEDClass I (EU MDR)
Ref PKA-14Model PKA-01, PKA-02, PKA-03, PKA-04, PKA-05, PS-01, PS-02, PS-03, PS-04, PS-05, PS-06, PA-01, PA-02, PA-03, PA-04, PA-05, PA-06, PD-S-01, PD-A-01
Identity
- Trade Name
- HAT 1 Scanning Kit EUDAMED
- Device Name
- Dental implant accessories EUDAMED
- Model / Reference
- PKA-01, PKA-02, PKA-03, PKA-04, PKA-05, PS-01, PS-02, PS-03, PS-04, PS-05, PS-06, PA-01, PA-02, PA-03, PA-04, PA-05, PA-06, PD-S-01, PD-A-01 EUDAMEDPKA-14 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975136231144 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 92de4396-98e7-4f95-ba2a-b9b0bef12dff 61 fields · synced Jun 17, 2026