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iSAFETM NIPT Kit with 6-color naica system:
EUDAMEDClass C (EU MDR)
Ref NIPT-100ASModel Ref: NIPT-100AS
Identity
- Trade Name
- iSAFETM NIPT Kit with 6-color naica system: EUDAMED
- Device Name
- iSAFETM NIPT Kit with naica 6-color system EUDAMED
- Model / Reference
- Ref: NIPT-100AS EUDAMEDNIPT-100AS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 01240000008708 EUDAMED
- Basic UDI-DI
- 12400000087NIPTA6S EUDAMED
- EMDN Code
- W0106010399 CHROMOSOMAL DISORDERS TESTS - OTHER EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
iSAFETM NIPT Kit with 6-color naica system: by Atila Biosystems Inc. — 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 | 12400000087NIPTA6S | Class C | Active |
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Manufacturer
- Manufacturer
- Atila Biosystems Inc.
- EUDAMED SRN
- US-MF-000023011
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED a6876be5-2bd1-4cde-b9f5-03238dd71aa1 61 fields · synced Jul 18, 2026