ATMOS S 61 CORIAN instruments
EUDAMEDFDA UDIClass I (EU MDR)
Identity
- Trade Name
- ATMOS S 61 CORIAN instruments EUDAMEDATMOS FDA UDI
- Generic Name
- ENT cabinet FDA UDI
- Model / Reference
- Cabinets, Instrument EUDAMED532.1000.0 EUDAMEDS 61 CORIAN® instruments FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250365190816 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503651ENTUnitS61CORinUD EUDAMED
- Direct Marketing DI
- 04250365190816 EUDAMED
- FDA Product Code
- ETF FDA UDI
- EMDN Code
- Z121402 ENT TREATMENT UNITS EUDAMED
- GMDN Term
- ENT cabinet FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 874.5300 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: ENT examination/treatment system
ATMOS S 61 CORIAN instruments by ATMOS MedizinTechnik GmbH & Co. KG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as ENT examination/treatment system.
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- Optomic — OPTOMIC ESPAÑA SA · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42503651ENTUnitS61CORinUD | 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 c4cf7589-b0ca-44bc-b4c0-c0b4f504c3dc 61 fields · synced Aug 4, 2026
- FDA UDI 2d6cdeec-efb0-4e6f-bb37-98ac045568af 32 fields · synced May 30, 2026