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RAMP Total b-hCG Controls Level 1
EUDAMEDClass IVD General (EU MDR)
Ref C4003-1Model RAMP Total b-hCG Controls - Level 1 (C4003-1)
Identity
- Trade Name
- RAMP Total b-hCG Controls Level 1 EUDAMED
- Device Name
- RAMP Total b-hCG Controls - Level 1 EUDAMED
- Model / Reference
- RAMP Total b-hCG Controls - Level 1 (C4003-1) EUDAMEDC4003-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10627966005312 EUDAMED
- Basic UDI-DI
- B-10627966005312 EUDAMED
- EMDN Code
- W010302080502 HAEMOSTASIS STANDARDS AND CALIBRATORS RT & POC EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
RAMP Total b-hCG Controls Level 1 by Response Biomedical Corp. — 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-10627966005312 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Response Biomedical Corp.
- EUDAMED SRN
- CA-MF-000034747
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 48ac0daa-0ac9-4826-a8e2-834cc221096f 61 fields · synced Jun 18, 2026