Electronic Nasopharyngeal Endoscope
by Shenzhen Insighters Medical Technology Co., Ltd. 29 variants
Ref /Model iS-HNF32, iS-HNF45, iS-HNC42, iS-HNC49, iS-HNC56, iS-HNF32L, iS-HNF45L, iS-HNC42L, iS-HNC49L, iS-HNC56L
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697780030HN3C 06977800306547 | Date28 Jul 2026 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- iS-HNF32, iS-HNF45, iS-HNC42, iS-HNC49, iS-HNC56, iS-HNF32L, iS-HNF45L, iS-HNC42L, iS-HNC49L, iS-HNC56L, /
- Primary DI / UDI-DI
- 06977800306547
- Basic UDI-DI
- 697780030HN3C
- Direct Marketing DI
- 06977800306547
- EMDN Code
- Z12021006 Video nasopharyngo/laryngoscopes
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000032018
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Other devices from Shenzhen Insighters Medical Technology Co., Ltd.
See all devices from Shenzhen Insighters Medical Technology Co., Ltd. →
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: 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