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OT - Radiation Protective Shields, Upper Body (including Portegra)
EUDAMEDFDA UDIClass I (EU MDR)
Ref OT80003-CNModel OTRef OT540034Ref OT500089Ref OT54001-CNRef OT510025Ref OT58001Ref OT0294-EMCRef OT80001
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 EUDAMEDOT80003-CN EUDAMEDOT540034 EUDAMEDOT500089 EUDAMEDOT54001-CN EUDAMEDOT510025 EUDAMEDOT58001 EUDAMEDOT0294-EMC EUDAMEDOT80001 EUDAMEDFDA UDI
- Description
- OT - Radiation Protective Shields, Upper Body (including Portegra) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04251339902725 EUDAMED04251339907287 EUDAMED04251339907270 EUDAMED04251339905894 EUDAMED04251339907263 EUDAMED04251339907294 EUDAMED04251339907669 EUDAMED04251339902664 EUDAMEDFDA UDI
- Basic UDI-DI
- 4251339900462VV EUDAMED
- Direct Marketing DI
- 04251339902725 EUDAMED04251339907287 EUDAMED04251339907270 EUDAMED04251339905894 EUDAMED04251339907263 EUDAMED04251339907294 EUDAMED04251339907669 EUDAMED04251339902664 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
- 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
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 (9)
- EUDAMED 1051af54-df36-403c-a305-47c000ba396a 61 fields · synced Jul 22, 2026
- EUDAMED 126cd149-6183-4c5b-84da-e5807e8f91ce 61 fields · synced May 17, 2026
- EUDAMED 2c95da0b-a0c5-42a7-a70c-e9df5f718708 61 fields · synced May 17, 2026
- EUDAMED 54b5699b-37b4-40b2-88b3-c772c88c5832 61 fields · synced May 17, 2026
- EUDAMED 1b834b5a-1209-4aa6-aac1-fcffee2370c8 61 fields · synced May 18, 2026
- EUDAMED 3c7cc62a-aa87-4e48-98f5-c54869586ccb 61 fields · synced May 18, 2026
- EUDAMED e6c51070-8d0b-41ba-b3a1-6dd55e2db091 61 fields · synced May 18, 2026
- EUDAMED 652a28f7-711e-4085-9bb8-d7a329b48fc7 61 fields · synced May 19, 2026
- FDA UDI a1efb72a-e9f5-43cf-80f6-522c4af3383b 33 fields · synced May 30, 2026