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BLS-1000 Battery Light Source Replacement
EUDAMEDFDA UDIClass I (EU MDR)
Ref 07-3050
Identity
- Trade Name
- BLS-1000 Battery Light Source Replacement EUDAMEDPortable LED Light Source FDA UDI
- Generic Name
- Endoscopic light source unit, battery-powered FDA UDI
- Device Name
- BLS-1000 Battery Light Source Replacement EUDAMED
- Model / Reference
- 07-3050 EUDAMEDBLS-1000 FDA UDI
Identifiers
- Catalog Number
- 07-3050 FDA UDI
- Primary DI / UDI-DI
- 00874485000318 EUDAMEDFDA UDI
- Basic UDI-DI
- 087448500BLS10008K EUDAMED
- 510(k) Number
- K100125 FDA UDI
- FDA Product Code
- EOB FDA UDI
- EMDN Code
- Z12020402 LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Endoscopic light source unit, battery-powered FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4760 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
No
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
No
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
No
FDA UDI
BLS-1000 Battery Light Source Replacement by Cogentix Medical, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 087448500BLS10008K | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Cogentix Medical, Inc.
- EUDAMED SRN
- US-MF-000041661
- Authorised Representative
- Medical Measurement Systems B.V. NL-AR-000010438
Sources (2)
- EUDAMED c30c07aa-14ff-4a7e-8c10-3058ecd8034b 61 fields · synced Aug 4, 2026
- FDA UDI 1ecef7bc-dc0e-4405-bc53-0f7b639ae190 35 fields · synced May 30, 2026