Identity
- Trade Name
- Laryngoscope blade EUDAMED
- Device Name
- Laryngoscope blade EUDAMED
- Model / Reference
- MAC1、MAC2、MAC3、MAC4 EUDAMEDMAC2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970831727541 EUDAMED
- Basic UDI-DI
- 697083172iS3MS3 EUDAMED
- Direct Marketing DI
- 06970831727541 EUDAMED
- EMDN Code
- Z12021099 ENT ENDOSCOPY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy 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
Laryngoscope blade by Shenzhen Insighters Medical Technology 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 | 697083172iS3MS3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Insighters Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000032018
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 9eaec351-6af5-4110-a327-bae21f0354db 61 fields · synced Jun 18, 2026