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ATMOS C 11 Systema (sitting)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 541.0000.0Model ENT treatment unit
Identity
- Trade Name
- ATMOS C 11 Systema (sitting) EUDAMEDATMOS FDA UDI
- Generic Name
- ENT cabinet FDA UDI
- Device Name
- The device is a diagnostic and therapy workplace for ENT specialists. The user can assemble the workplace with options and accessories according to his personal requirements. The device is used in clinics or ENT offices. FDA UDI
- Model / Reference
- ENT treatment unit EUDAMED541.0000.0 EUDAMEDC 11 Systema (sitting) FDA UDI
- Description
- The device is a diagnostic and therapy workplace for ENT specialists. The user can assemble the workplace with options and accessories according to his personal requirements. The device is used in clinics or ENT offices. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250365175417 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250365175417 EUDAMED
- FDA Product Code
- ETF FDA UDI
- EMDN Code
- Z121402 ENT TREATMENT UNITS EUDAMED
- GMDN Term
- ENT cabinet FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.5300 FDA UDI
- Market of Registration
- Germany 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: ENT examination/treatment system
ATMOS C 11 Systema (sitting) by ATMOS MedizinTechnik GmbH & Co. KG — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as ENT examination/treatment system.
- Wall diagnostic ri-former® 2 handles 3.5 V / 120 V without clock — Rudolf Riester GmbH & Co. KG · Class II
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Optomic — OPTOMIC ESPAÑA SA · Class I
- Extension module, 1 handle, ri-former® — Rudolf Riester GmbH & Co. KG · Class II
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Novo Surgical Inc. — NOVO SURGICAL, INC. · Class I
- Optomic — OPTOMIC ESPAÑA SA · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04250365175417 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ATMOS MedizinTechnik GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005570
Sources (2)
- EUDAMED 55e50ce2-dab9-4b4a-8ad5-4a9458cefa0b 61 fields · synced Jun 19, 2026
- FDA UDI 4813daa9-a6a0-4085-ae84-20885390a50a 33 fields · synced May 30, 2026