Identity
- Trade Name
- Retrograde IR Platform and Extension EUDAMEDAdept Medical IR platform + Extension FDA UDI
- Generic Name
- Instrument table FDA UDI
- Device Name
- Retrograde IR Platform and Extension EUDAMEDSupport Furniture FDA UDI
- Model / Reference
- AM0420 EUDAMEDFDA UDI
- Description
- Support Furniture FDA UDI
Identifiers
- Catalog Number
- AM0420 FDA UDI
- Primary DI / UDI-DI
- 09421902825828 EUDAMEDFDA UDI
- Basic UDI-DI
- 942190282582AM0420VX EUDAMED
- FDA Product Code
- KMN FDA UDI
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Instrument table FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6140 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Liquid Chemical FDA UDI
Retrograde IR Platform and Extension by Adept Medical 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 | 942190282582AM0420VX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Adept Medical Ltd
- EUDAMED SRN
- NZ-MF-000003374
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED 4d2101d3-ee11-45a8-8cd8-1ae27559f3b4 61 fields · synced Aug 3, 2026
- FDA UDI bebf6f40-84f3-459c-aa9e-f3597ad38e11 35 fields · synced May 30, 2026