Identity
- Trade Name
- AmplideX DM1 Dx Kit EUDAMED
- Device Name
- AmplideX DM1 Dx Kit EUDAMED
- Model / Reference
- 76048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00863840000261 EUDAMED
- Basic UDI-DI
- B-00863840000261 EUDAMED
- EMDN Code
- W0106010118 MYOTONIC DYSTROPHY TYPE 1 OR STEINERT'S DISEASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
AmplideX DM1 Dx Kit by Asuragen, Inc. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-00863840000261 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Asuragen, Inc.
- EUDAMED SRN
- US-MF-000011830
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED b67e834c-60d7-4640-a23d-7ce6e0d1d5ee 61 fields · synced Jun 19, 2026