Identity
- Trade Name
- Retrograde IR Platform Extension EUDAMEDAdept Medical IR Extension FDA UDI
- Generic Name
- Instrument table FDA UDI
- Device Name
- Retrograde IR Platform Extension EUDAMEDSupport Furniture, accessory to IR Platform FDA UDI
- Model / Reference
- AM0410 EUDAMEDAM410 FDA UDI
- Description
- Support Furniture, accessory to IR Platform FDA UDI
Identifiers
- Catalog Number
- AM0410 FDA UDI
- Primary DI / UDI-DI
- 09421902825811 EUDAMEDFDA UDI
- Basic UDI-DI
- 942190282581AM0410VB 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Electromagnetic surgical navigation device tracking system
Retrograde IR Platform Extension by Adept Medical Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 942190282581AM0410VB | 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 1c6623e1-cdf9-404f-a03f-d01c6aea23bd 61 fields · synced Jun 18, 2026
- FDA UDI 4e965495-e794-49fc-b0b3-b511e84bcd46 34 fields · synced May 30, 2026