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MD 62 System Receiver
EUDAMEDFDA UDIClass I (EU MDR)
Ref MDWL2_B1J1RX
by Amimon Ltd.
Identity
- Trade Name
- MD 62 System Receiver EUDAMEDAmimon FDA UDI
- Generic Name
- Medical image management system FDA UDI
- Device Name
- MD 62 System Receiver EUDAMED
- Model / Reference
- MDWL2_B1J1RX EUDAMEDMD62 System - MDWL2_B1J1RX FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817157020757 EUDAMEDFDA UDI
- Basic UDI-DI
- 817157020757CZ EUDAMED
- FDA Product Code
- OUG FDA UDI
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
- GMDN Term
- Medical image management system FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6310 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MD 62 System Receiver by Amimon Ltd — 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 | 817157020757CZ | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Amimon Ltd.
- EUDAMED SRN
- IL-MF-000036491
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED b5229eda-7ae6-490c-a3b7-390c1154fe96 61 fields · synced Jul 8, 2026
- FDA UDI 425bc214-39e7-42e7-a451-b217c662a0bc 32 fields · synced May 30, 2026