Identity
- Trade Name
- 511 T-Vial Shield EUDAMEDCapintec 511 T-Vial Shield FDA UDI
- Generic Name
- Vial radiation shield FDA UDI
- Device Name
- Vial Shield EUDAMED511 T-Vial Shield FDA UDI
- Model / Reference
- 5530-2014 EUDAMEDFDA UDI
- Description
- 511 T-Vial Shield FDA UDI
Identifiers
- Catalog Number
- 5530-2014 FDA UDI
- Primary DI / UDI-DI
- 00859942006317 EUDAMEDFDA UDI
- Basic UDI-DI
- 08599420061034W EUDAMED
- FDA Product Code
- IWW FDA UDI
- EMDN Code
- Z11029099 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - OTHER EUDAMED
- GMDN Term
- Vial radiation shield 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
511 T-Vial Shield by Mirion Technologies (Capintec), Inc. — 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 | 08599420061034W | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mirion Technologies (Capintec), Inc.
- EUDAMED SRN
- US-MF-000000770
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (2)
- EUDAMED ae6d4a43-9b03-4363-bae5-9da8ae72a4fb 61 fields · synced Jun 20, 2026
- FDA UDI 011c1022-be9d-4d00-a360-6f04c9d9a3ab 35 fields · synced May 30, 2026