ATMOS LS 21 LED, warm white
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- ATMOS LS 21 LED, warm white EUDAMEDATMOS FDA UDI
- Generic Name
- Endoscopic light source unit, line-powered FDA UDI
- Device Name
- ATMOS LS 21 LED EUDAMEDThe device is intended to illuminate natural orifices (e.g. ear/nose/throat) for visual diagnosis. FDA UDI
- Model / Reference
- Light Sources EUDAMED507.4602.0 EUDAMEDLS 21 LED, warm white FDA UDI
- Description
- The device is intended to illuminate natural orifices (e.g. ear/nose/throat) for visual diagnosis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250365174434 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503651ENTVisLS21R8 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 21 LED, warm white 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 | 42503651ENTVisLS21R8 | 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 6d009957-74ea-4565-b4d8-91cfa2b1b6e2 61 fields · synced Jul 13, 2026
- FDA UDI 9beee394-3ba6-47c3-92e2-1e3680b2a898 33 fields · synced May 30, 2026