Hitecare
by Ningbo Boya Medical Equipment Co., Ltd
Part of a family of 23 devices: see the family page
Ref GZ-GL-5Model GZ-GL-1/GZ-GL-2/GZ-GL-3/GZ-GL-3(A)/GZ-GL-3(B)/GZ-GL-4/GZ-GL-4(A)/GZ-GL-4(B)/GZ-GL-5/GZ-GL-5(A)/GZ-GL-5(B)/GZ-GL-6/GZ-GL-7/GZ-GL-8/GZ-GL-9
Hitecare (GZ-GL-5) is a Class IIa device made by Ningbo Boya Medical Equipment Co., Ltd, registered in EUDAMED on 8 Oct 2024 (Basic UDI-DI 69514674120001WA), active as of 22 Oct 2026.
Active
CE MDR
Valid until
No date given
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69514674120001WA 06951467490184 | Date8 Oct 2024 | StatusActive |
Official records
- EUDAMED public site 69514674120001WA
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- GZ-GL-1/GZ-GL-2/GZ-GL-3/GZ-GL-3(A)/GZ-GL-3(B)/GZ-GL-4/GZ-GL-4(A)/GZ-GL-4(B)/GZ-GL-5/GZ-GL-5(A)/GZ-GL-5(B)/GZ-GL-6/GZ-GL-7/GZ-GL-8/GZ-GL-9, GZ-GL-5
- Primary DI / UDI-DI
- 06951467490184
- Basic UDI-DI
- 69514674120001WA
- EMDN code
- R040101 Antibacterial and antiviral respiratory filters
- Device class
- Class IIa
- EU registration type
- Standard device
- EU market of registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000032282
- Authorised representative
- Caretechion GmbH DE-AR-000005946
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