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Angiography Contrast Delivery Systems PRESS DUO elite
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref Many
Identity
- Trade Name
- Angiography Contrast Delivery Systems PRESS DUO elite EUDAMEDPRESS DUO elite FDA UDI
- Generic Name
- Angiography contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- Angiography Contrast Delivery Systems PRESS DUO elite EUDAMEDNemoto PRESS DUO elite dual-head angiographic contrast delivery system, separate type unit. FDA UDI
- Model / Reference
- Many EUDAMED260 FDA UDI
- Description
- Nemoto PRESS DUO elite dual-head angiographic contrast delivery system, separate type unit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04560138482605 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04560138482605 EUDAMED
- 510(k) Number
- K173450 FDA UDI
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- Z11039014 MULTIPLE CONTRAST AGENT INJECTORS EUDAMED
- GMDN Term
- Angiography contrast medium injection system, line-powered, mobile FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- Belgium 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Angiography Contrast Delivery Systems PRESS DUO elite by Nemoto Kyorindo Co., Ltd. — Class IIb — MDD, FDA UDI — listed in EUDAMED, FDA GUDID
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04560138482605 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Nemoto Kyorindo Co., Ltd.
- EUDAMED SRN
- JP-MF-000004827
- Authorised Representative
- Medicor International NV/SA BE-AR-000003308
Sources (2)
- EUDAMED 6a2e0a25-ce96-48f6-aed8-92709ef3cf94 61 fields · synced Jul 31, 2026
- FDA UDI 17453abb-1186-4766-9475-c2f338ddb549 35 fields · synced May 30, 2026