Identity
- Trade Name
- EMBRYO BIOPSY KIT (60ud) EUDAMED
- Device Name
- Embryo Biopsy Kit EUDAMED
- Model / Reference
- FL1054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08437026899028 EUDAMED
- Basic UDI-DI
- 8437026899EBKE9 EUDAMED
- EMDN Code
- W05019099 SAMPLES COLLECTION DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
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
New Device
No
EUDAMED
EMBRYO BIOPSY KIT (60ud) by Juno Genetics España — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 8437026899EBKE9 | Class A | Active |
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Manufacturer
- Manufacturer
- Juno Genetics España
- EUDAMED SRN
- ES-MF-000045150
Sources (1)
- EUDAMED 1b8c74c3-30fe-456f-95ac-3d4cf49bc08f 61 fields · synced Jul 29, 2026