Atmos Ls 21 LED
by ATMOS MedizinTechnik GmbH & Co. KG
Ref 507.4600.0Model Light Sources
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number04250365155839 | Date27 Nov 2024 | StatusListed |
| European Union | CE/MDR EUDAMED | Number42503651ENTVisLS21R8 04250365155839 | Date10 Jun 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Atmos Ls 21 LED EUDAMEDAtmos GUDID
- Generic Name
- Endoscopic light source unit, line-powered
- Model / Reference
- Light Sources EUDAMED507.4600.0 EUDAMEDLS 21 LED GUDID
- Primary DI / UDI-DI
- 04250365155839
- Basic UDI-DI
- 42503651ENTVisLS21R8
- FDA Product Code
- KZF
- EMDN Code
- Z12020402 Light sources for endoscopy and minimally invasive surgery
- GMDN Term
- Endoscopic light source unit, line-powered
- Device Class
- Class I
- Regulation Number
- 880.6320
- EU market of registration
- Germany
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Light Sources 507.4600.0 | LS 21 LED |
Manufacturer details
- EUDAMED SRN
- DE-MF-000005570
Other devices from ATMOS MedizinTechnik GmbH & Co. KG
Properties
Other properties (21)
- 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
- Lot / Batch Number: No
- Expiration Date: No