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Scopes
EUDAMEDClass I (EU MDR)
Ref VRN-1030Model VOT-1000(E-monitor);VRN-1010,VRN-1020,VRN-1030, VRN-1040,VRN-1050,VRN-1060,VRN-1080,VRN-1090, OTT-1010,VFL-1010,VRN-102S, VRN-104S,VRN-101R, VRN-105R(Scopes)
Identity
- Trade Name
- Scopes EUDAMED
- Device Name
- E-pocket(E-monitor and Scopes) EUDAMED
- Model / Reference
- VOT-1000(E-monitor);VRN-1010,VRN-1020,VRN-1030, VRN-1040,VRN-1050,VRN-1060,VRN-1080,VRN-1090, OTT-1010,VFL-1010,VRN-102S, VRN-104S,VRN-101R, VRN-105R(Scopes) EUDAMEDVRN-1030 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971355352691 EUDAMED
- Basic UDI-DI
- 69713553526539M EUDAMED
- Direct Marketing DI
- 06971355352691 EUDAMED
- EMDN Code
- Z12021006 VIDEO NASOPHARYNGO/LARYNGOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Scopes by Shenzhen Besdata 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 | 69713553526539M | Class I | Active |
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Manufacturer
- Manufacturer
- Shenzhen Besdata Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000018921
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e5559a00-6ee5-4329-b710-9622fc7bae30 61 fields · synced Jun 19, 2026