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Prenatal 13 and 21 Enumeration Probe kit
EUDAMEDClass C (EU MDR)
Ref CE-LPA 003-SRef CE-LPA 003
Identity
- Trade Name
- Prenatal 13 and 21 Enumeration Probe kit EUDAMED
- Device Name
- Prenatal 13 and 21 Enumeration Probe kit EUDAMED
- Model / Reference
- CE-LPA 003-S EUDAMEDCE-LPA 003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05055844906051 EUDAMED05055844906044 EUDAMED05055844927711 EUDAMED
- Basic UDI-DI
- 50558449LPA003GL EUDAMED
- EMDN Code
- W0106010301,W0106010304 EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
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
Prenatal 13 and 21 Enumeration Probe kit by Cytocell Limited — Class C — 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 | 50558449LPA003GL | Class C | Active |
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Manufacturer
- Manufacturer
- Cytocell Limited
- EUDAMED SRN
- GB-MF-000016893
- Authorised Representative
- Sysmex Europe SE DE-AR-000022333
Sources (3)
- EUDAMED d14b798a-b48d-4892-aa47-8a95c6f0958f 61 fields · synced Jul 27, 2026
- EUDAMED f63eeb70-8bd1-4fb5-b8a6-1567cfcca3dd 61 fields · synced May 19, 2026
- EUDAMED 9b947f2f-1375-4bcf-9bc0-3a51d5cd5a75 61 fields · synced May 19, 2026