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Ramp 200
EUDAMEDFDA UDIClass A (EU MDR)
Ref C2100Model RAMP 200 (C2100 and C3100)
Identity
- Trade Name
- RAMP 200 EUDAMEDRAMP® 200 CM Control Module FDA UDI
- Generic Name
- Fluorescent immunoassay analyser IVD, point-of-care FDA UDI
- Device Name
- RAMP 200 Instrument EUDAMED
- Model / Reference
- RAMP 200 (C2100 and C3100) EUDAMEDC2100 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 10627966005237 EUDAMEDFDA UDI
- Basic UDI-DI
- 627966RAMP200CR EUDAMED
- Direct Marketing DI
- 10627966005237 EUDAMED
- 510(k) Number
- K071591 FDA UDI
- FDA Product Code
- KHO FDA UDI
- EMDN Code
- W0201020201 IMMUNOCHEMISTRY READERS EUDAMED
- GMDN Term
- Fluorescent immunoassay analyser IVD, point-of-care FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 862.2560 FDA UDI
- Market of Registration
- Romania EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Ramp 200 by Response Biomedical Corp. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 627966RAMP200CR | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Response Biomedical Corp.
- EUDAMED SRN
- CA-MF-000034747
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED f2ab9259-c466-4760-a131-921e7c022528 61 fields · synced Jul 24, 2026
- FDA UDI a27e1420-533d-4772-96cf-7b7d40620a35 33 fields · synced May 30, 2026