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HeadSTEP iBEAM evo Extension Basic Module
EUDAMEDFDA UDIClass I (EU MDR)
Ref P10107-402
Identity
- Trade Name
- HeadSTEP iBEAM evo Extension Basic Module EUDAMEDFDA UDI
- Generic Name
- Radiological whole-body positioner FDA UDI
- Device Name
- Extensions EUDAMED
- Model / Reference
- P10107-402 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120074394025 EUDAMEDFDA UDI
- Basic UDI-DI
- 91200743939ME EUDAMED
- Direct Marketing DI
- 09120074394025 EUDAMED
- 510(k) Number
- K081218 FDA UDI
- FDA Product Code
- IYE FDA UDI
- EMDN Code
- Z12011280 PATIENT POSITIONING INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Radiological whole-body positioner FDA UDI
Classification
- Device Class
- Class I 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
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
HeadSTEP iBEAM evo Extension Basic Module by IT-V Medizintechnik GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 91200743939ME | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- IT-V Medizintechnik GmbH
- EUDAMED SRN
- AT-MF-000001918
Sources (2)
- EUDAMED 742ce1b8-c9eb-4e54-b633-922bb53349ab 61 fields · synced Jul 11, 2026
- FDA UDI 9aa3f40f-2b79-42f8-b101-5869a3b4f690 33 fields · synced May 30, 2026