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Jetfall Medical Carbon Dioxide Angiographic Injector and Accessories
EUDAMEDClass I (EU MDR)
Ref AMTY-EU001
Identity
- Trade Name
- Jetfall Medical Carbon Dioxide Angiographic Injector and Accessories EUDAMED
- Device Name
- Medical Carbon Dioxide Angiographic Injector and Accessories EUDAMED
- Model / Reference
- AMTY-EU001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973364962892 EUDAMED
- Basic UDI-DI
- 697336496AMTY-EU58 EUDAMED
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Angiography kit
Jetfall Medical Carbon Dioxide Angiographic Injector and Accessories by AMT Medical Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Angiography kit.
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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 | 697336496AMTY-EU58 | Class I | Active |
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Manufacturer
- Manufacturer
- AMT Medical Inc.
- EUDAMED SRN
- CN-MF-000009651
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 91482326-3194-4e6f-8141-ae2157b8aa2e 61 fields · synced Jul 30, 2026