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STA Compact Max® 2
EUDAMEDFDA UDIClass A (EU MDR)
Ref 58989Model STA Compact Max
Identity
- Trade Name
- STA Compact Max® 2 EUDAMEDSTA Compact Max® (with cap piercing option) FDA UDI
- Generic Name
- Coagulation analyser IVD, laboratory FDA UDI
- Model / Reference
- STA Compact Max EUDAMED58989 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03607450589894 EUDAMEDFDA UDI
- Basic UDI-DI
- 3607450INST0003UH EUDAMED
- Direct Marketing DI
- 03607450589894 EUDAMED
- FDA Product Code
- JPA FDA UDI
- EMDN Code
- W0202029099 VARIOUS HEMOSTASIS INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Coagulation analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5425 FDA UDI
- Market of Registration
- France 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
Yes
FDA UDI
STA Compact Max® 2 by Diagnostica Stago — 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 | 3607450INST0003UH | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Diagnostica Stago
- EUDAMED SRN
- FR-MF-000017089
Sources (2)
- EUDAMED 8ade0ae5-63ac-4323-8bae-6cd16b8f0a0c 61 fields · synced Jun 18, 2026
- FDA UDI 475d4cc6-524d-44c8-9970-0592ae27b50e 32 fields · synced May 30, 2026