Identity
- Trade Name
- Chroma ATE EUDAMED
- Device Name
- Spin tips in rack EUDAMED
- Model / Reference
- A94-000172 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719889100157 EUDAMED
- Basic UDI-DI
- 471988910spintipV6 EUDAMED
- Unit of Use DI
- 04719889100119 EUDAMED
- EMDN Code
- W02060185 ROBOTIC SAMPLE PROCESSING SYSTEMS - CONSUMABLES 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
Yes
EUDAMED
New Device
No
EUDAMED
Chroma ATE by Chroma Ate Inc. — 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 | 471988910spintipV6 | Class A | Active |
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Manufacturer
- Manufacturer
- Chroma Ate Inc.
- EUDAMED SRN
- TW-MF-000019529
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED ee781fe5-0b08-437e-b721-864fc8876b02 61 fields · synced Jun 19, 2026