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Staphaurex Disposable Reaction Cards (50 cards per pack)
EUDAMEDFDA UDIClass B (EU MDR)
Ref R30369001
Identity
- Trade Name
- Staphaurex Disposable Reaction Cards (50 cards per pack) EUDAMEDStreptex Disposable Reaction Cards RT02 FDA UDI
- Generic Name
- Beta-haemolytic Streptococcus serological grouping IVD, control FDA UDI
- Device Name
- STAPHAUREX DISPOSABLE REACTION CARDS EUDAMED
- Model / Reference
- R30369001 EUDAMEDR30368601 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05056080501543 EUDAMEDFDA UDI
- Basic UDI-DI
- 50560805StapharexCardsBK EUDAMED
- FDA Product Code
- JTO FDA UDI
- EMDN Code
- W0104080399 IMMUNOLOGICAL IDENTIFICATION - OTHER EUDAMED
- GMDN Term
- Beta-haemolytic Streptococcus serological grouping IVD, control FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass I FDA UDI
- Regulation Number
- 866.2660 FDA UDI
- Market of Registration
- Netherlands 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
No
EUDAMED
New Device
No
EUDAMED
Prescription Use
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Staphaurex Disposable Reaction Cards (50 cards per pack) by Remel Europe Ltd — Class B — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 50560805StapharexCardsBK | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Remel Europe Ltd
- EUDAMED SRN
- GB-MF-000016733
- Authorised Representative
- Thermo Fisher Diagnostics B.V. NL-AR-000013157
Sources (2)
- EUDAMED 22c7b881-826a-47a0-9f9b-647ee2d93b05 61 fields · synced Jun 18, 2026
- FDA UDI dd06d6c1-d9a4-4e50-b639-ac3d742c0614 33 fields · synced May 30, 2026