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Aktina Breathing Coordinator Control Module
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref 12-200-01
Identity
- Trade Name
- AKTINA BREATHING COORDINATOR CONTROL MODULE EUDAMEDActive Breathing Coordinator FDA UDI
- Generic Name
- Real-time position management respiratory gating system, optical FDA UDI
- Device Name
- ACTIVE BREATHING COORDINATOR CONTROL MODULE EUDAMEDControl Module, Active Breathing Coordinator FDA UDI
- Model / Reference
- 12-200-01 EUDAMED1528859 FDA UDI
- Description
- Control Module, Active Breathing Coordinator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060191071284 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060191071284 EUDAMED
- 510(k) Number
- K151097 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z11010199 LINEAR ACCELERATORS – OTHER EUDAMED
- GMDN Term
- Real-time position management respiratory gating system, optical FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Market of Registration
- Austria 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
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Aktina Breathing Coordinator Control Module by Aktina Medical Corp — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Manufacturer's product page: Request an Aktina Medical Active Breathing Coordinator User Manual
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-05060191071284 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Aktina Medical Corp
- EUDAMED SRN
- US-MF-000005935
- Authorised Representative
- European Healthcare & Device Solutions Ltd. IE-AR-000003999
Sources (2)
- EUDAMED 0f214039-bd4c-4ab9-89d7-1b0ba0ddcdb7 61 fields · synced Jun 19, 2026
- FDA UDI b2b913d8-5fc7-4d5a-bf4e-a03a32e3f628 35 fields · synced May 29, 2026