Identity
- Trade Name
- VLS-55Q EUDAMEDSonoScape FDA UDI
- Generic Name
- Endoscopic light source unit, line-powered FDA UDI
- Device Name
- Light Source EUDAMEDVLS-55Q Light Source FDA UDI
- Model / Reference
- VLS-55Q, VLS-55T EUDAMED/ EUDAMEDVLS-55Q FDA UDI
- Description
- VLS-55Q Light Source FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945868603601 EUDAMEDFDA UDI
- Basic UDI-DI
- 69458686VLS-555D EUDAMED
- 510(k) Number
- K211882 FDA UDI
- FDA Product Code
- NWB FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Endoscopic light source unit, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic light source unit, line-powered
Vls-55q by Sonoscape Medical Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic light source unit, line-powered.
- Light Sources, Fiberoptic — STEMA Medizintechnik GmbH · Class I
- SPOTLIGHT ACCESS SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
- Endoscope Light Source — Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class I
- LED 610 Light source — Erbe Vision GmbH · Class I
- SPOTLIGHT — Depuy Spine, Inc. · Class II
- FUJIFILM — FUJIFILM Corporation · Class II
- SPOTLIGHT ACCESS SYSTEM — MEDOS INTERNATIONAL SARL · Class IIa
- Medical Endoscope Cold Light Source — Shenzhen Medmicro Medical Technology Co., Ltd · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69458686VLS-555D | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sonoscape Medical Corp.
- EUDAMED SRN
- CN-MF-000009623
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 7657250b-8ec2-48e8-a994-d91f123a3f43 61 fields · synced Jun 19, 2026
- FDA UDI 44646371-359a-4be9-8ad2-9c1ab0eaedff 34 fields · synced May 30, 2026