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Chroma ATE
EUDAMEDClass A (EU MDR)
Ref G32-016337Ref G32-017505Ref G32-016336Ref A94-000173
Identity
- Trade Name
- Chroma ATE EUDAMED
- Device Name
- Sample drawer EUDAMEDSpin tips in rack EUDAMED
- Model / Reference
- G32-016337 EUDAMEDG32-017505 EUDAMEDG32-016336 EUDAMEDA94-000173 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719889100058 EUDAMED04719889100164 EUDAMED04719889100027 EUDAMED04719889100140 EUDAMED
- Basic UDI-DI
- 471988910drawerTZ EUDAMED471988910spintipV6 EUDAMED
- Unit of Use DI
- 04719889100119 EUDAMED
- EMDN Code
- W02060180 ROBOTIC SAMPLE PROCESSING SYSTEMS - HARDWARE ACCESSORIES EUDAMEDW02060185 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 | 471988910drawerTZ | 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 (4)
- EUDAMED 4638902b-0ea2-4c24-ba96-00f13afd73f7 61 fields · synced Aug 1, 2026
- EUDAMED 8e7c4a51-ac04-4f60-806b-05038364481f 61 fields · synced May 17, 2026
- EUDAMED db3bcf31-84df-4ae4-9047-0006d9e42238 61 fields · synced May 18, 2026
- EUDAMED b706628f-4263-4487-aa05-a0de65d20556 61 fields · synced May 19, 2026