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SYRINGE SHIELD, PET/MRI, W/GLASS, 3cc
EUDAMEDClass I (EU MDR)
Ref 007-961Model 511 Dose Drawing Syringe Shield, 5cc
Identity
- Trade Name
- SYRINGE SHIELD, PET/MRI, W/GLASS, 3cc EUDAMED
- Model / Reference
- 511 Dose Drawing Syringe Shield, 5cc EUDAMED007-961 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00879942070187 EUDAMED
- Basic UDI-DI
- 08599420061024U EUDAMED
- EMDN Code
- Z11029099 VARIOUS INSTRUMENTS FOR NUCLEAR MEDICINE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
SYRINGE SHIELD, PET/MRI, W/GLASS, 3cc by Mirion Technologies (Capintec), Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08599420061024U | Class I | Active |
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Manufacturer
- Manufacturer
- Mirion Technologies (Capintec), Inc.
- EUDAMED SRN
- US-MF-000000770
- Authorised Representative
- Atlantico Systems, Ltd. IE-AR-000000208
Sources (1)
- EUDAMED 6620f765-b1fb-43a3-8c8a-b5ae04a91786 61 fields · synced Sep 18, 2026