HAT 1 Scanning Kit
by Ziyang Freqty Medical Equipment Co., Ltd. 60 variants
Ref PKA-56Model 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
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697513623PTHAT1RS 06975136231564 | Date18 Jul 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Dental implant accessories
- 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, PKA-56
- Primary DI / UDI-DI
- 06975136231564
- Basic UDI-DI
- 697513623PTHAT1RS
- Direct Marketing DI
- 06975136231564
- EMDN Code
- P01020180 Dental implants - accessories
- Device Class
- Class I
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CN-MF-000019421
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties
Other properties (12)
- Sterile: No
- Implantable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No