Atmos Ls 31 Led
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- ATMOS LS 31 LED EUDAMEDATMOS FDA UDI
- Generic Name
- Endoscopic light source unit, line-powered FDA UDI
- Device Name
- ATMOS LS 31 LED (S 61 Servant vision) EUDAMEDThe product is a cold light source for medical use. In combination with a light guide cable and an instrument connected to it, the light source enables the illumination of the viewing area for diagnostic purposes. FDA UDI
- Model / Reference
- Light Sources EUDAMED507.4800.0 EUDAMEDLS 31 LED FDA UDI
- Description
- The product is a cold light source for medical use. In combination with a light guide cable and an instrument connected to it, the light source enables the illumination of the viewing area for diagnostic purposes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250365189797 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503651ENTVisLS31RB EUDAMED
- Direct Marketing DI
- 04250365189797 EUDAMED
- FDA Product Code
- KZF 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 I EUDAMEDFDA UDI
- Regulation Number
- 880.6320 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
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
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Endoscopic light source unit, line-powered
Atmos Ls 31 Led by ATMOS MedizinTechnik GmbH & Co. KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42503651ENTVisLS31RB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ATMOS MedizinTechnik GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005570
Sources (2)
- EUDAMED 61f89908-7baf-4444-a5a9-d9988b32d178 61 fields · synced Jul 10, 2026
- FDA UDI 9fd93ca6-4dc2-4a87-bc89-2fd0e70151fb 33 fields · synced May 30, 2026