Identity
- Trade Name
- iSED EUDAMEDFDA UDI
- Generic Name
- Erthrocyte sedimentation rate (ESR) analyser IVD FDA UDI
- Device Name
- iSED Automated ESR Analyzer EUDAMEDAutomated Erythrocyte Sedimentation Rate Analyzer FDA UDI
- Model / Reference
- 112-00101 EUDAMEDFDA UDI
- Description
- Automated Erythrocyte Sedimentation Rate Analyzer FDA UDI
Identifiers
- Catalog Number
- 112-00101 FDA UDI
- Primary DI / UDI-DI
- 00896406002508 EUDAMEDFDA UDI
- Basic UDI-DI
- 0896406002iSED2Elite5D EUDAMED
- Direct Marketing DI
- 00896406002508 EUDAMED
- FDA Product Code
- GKB FDA UDI
- EMDN Code
- W02029001 ERYTHROCYTE SEDIMENTATION RATE DEVICES EUDAMED
- GMDN Term
- Erthrocyte sedimentation rate (ESR) analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.5800 FDA UDI
- Market of Registration
- Croatia 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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
iSED by Alcor Scientific — 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 | 0896406002iSED2Elite5D | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Alcor Scientific
- EUDAMED SRN
- US-MF-000029295
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 1520460a-c31a-4c97-bdc8-c4f14da663bb 61 fields · synced Aug 4, 2026
- FDA UDI 2dcbd174-8ce9-4550-b4c3-18dacc831e85 34 fields · synced May 30, 2026