Identity
- Trade Name
- BreastSTEP Long MR Basic Module EUDAMEDFDA UDI
- Generic Name
- Radiological chest positioner FDA UDI
- Device Name
- BreastSTEP Base EUDAMED
- Model / Reference
- P10107-543 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 09120074395435 EUDAMEDFDA UDI
- Basic UDI-DI
- 91200743964MD EUDAMED
- Direct Marketing DI
- 09120074395435 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 chest 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
Yes
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
MR Safe FDA UDI
BreastSTEP Long MR 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 | 91200743964MD | 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 c87ecdb7-1289-46ca-9fe8-db7d15c2f860 61 fields · synced Jun 20, 2026
- FDA UDI 8d5ad3ae-e870-41b1-b17b-e21b4fcdfad2 33 fields · synced May 30, 2026