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OT - Radiation Protective Shields, Upper Body (including Portegra)
EUDAMEDFDA UDIClass I (EU MDR)
Ref OT50002-USModel OT
by MAVIG GmbH
Identity
- Trade Name
- OT - Radiation Protective Shields, Upper Body (including Portegra) EUDAMEDOT FDA UDI
- Generic Name
- Radiation shielding panel, fixed FDA UDI
- Device Name
- OT - Radiation Protective Shields, Upper Body (including Portegra) EUDAMEDFDA UDI
- Model / Reference
- OT EUDAMEDOT50002-US EUDAMEDFDA UDI
- Description
- OT - Radiation Protective Shields, Upper Body (including Portegra) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04251339902558 EUDAMEDFDA UDI
- Basic UDI-DI
- 4251339900462VV EUDAMED
- Direct Marketing DI
- 04251339902558 EUDAMED
- FDA Product Code
- EAK FDA UDI
- EMDN Code
- T030403 RADIOTHERAPY PROTECTIVE SCREENS EUDAMED
- GMDN Term
- Radiation shielding panel, fixed FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 892.6500 FDA UDI
- 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
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
No
FDA UDI
OT - Radiation Protective Shields, Upper Body (including Portegra) by MAVIG GmbH — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 4251339900462VV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- MAVIG GmbH
- EUDAMED SRN
- DE-MF-000006207
Sources (2)
- EUDAMED 0acb1da2-a20f-4b52-aa1e-e6390b1b866e 61 fields · synced Jun 19, 2026
- FDA UDI 742280f7-ac64-4881-a644-39f84dce1913 33 fields · synced May 30, 2026