Identity
- Trade Name
- Antegrade Platform EUDAMED
- Device Name
- Antegrade EUDAMED
- Model / Reference
- AM0440 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09421905187282 EUDAMED
- Basic UDI-DI
- 942190518728AM0440ZB EUDAMED
- EMDN Code
- Z11039099 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Electromagnetic surgical navigation device tracking system
Antegrade Platform by Adept Medical Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Electromagnetic surgical navigation device tracking system.
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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 | 942190518728AM0440ZB | Class I | Active |
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Manufacturer
- Manufacturer
- Adept Medical Ltd
- EUDAMED SRN
- NZ-MF-000003374
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (1)
- EUDAMED a2d3b2bd-cf16-4c2e-9131-a7564451af9a 61 fields · synced Jul 19, 2026