Identity
- Trade Name
- Bar Phantom, GE, 3.2, 4.0, 4.8 and 6.4 mm EUDAMED
- Device Name
- Bar Phantom EUDAMED
- Model / Reference
- 243-815 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00859942006478 EUDAMED
- Basic UDI-DI
- 08599420061044Y EUDAMED
- Direct Marketing DI
- 00859942006478 EUDAMED
- EMDN Code
- Z11020280 INTEGRATED CT/GAMMA CAMERA SYSTEMS - HARDWARE ACCESSORIES 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
Bar Phantom, GE, 3.2, 4.0, 4.8 and 6.4 mm 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 | 08599420061044Y | 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 915c20f4-f14b-4b81-ae1d-d8628974da4d 61 fields · synced Jul 15, 2026