Identity
- Device Name
- Congenica Rare Disease EUDAMED
- Model / Reference
- 101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 50610078000366 EUDAMED
- Basic UDI-DI
- B-50610078000366 EUDAMED
- EMDN Code
- W02050192 NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Special Device Type
- -1202 EUDAMED
- Market of Registration
- Ireland 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
Congenica Rare Disease by Congenica Ltd — 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-50610078000366 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Congenica Ltd
- EUDAMED SRN
- GB-MF-000026168
- Authorised Representative
- Acorn Regulatory Consultancy Services Ltd IE-AR-000000592
Sources (1)
- EUDAMED 0934cc24-00df-4c1b-a14c-4b98e36285a9 61 fields · synced Jul 16, 2026