Identity
- Trade Name
- iSED PRO EUDAMED
- Device Name
- iSED PRO Series S EUDAMED
- Model / Reference
- 112-00120-SYS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00850028040058 EUDAMED
- Basic UDI-DI
- 0850028040iSEDPROLT EUDAMED
- EMDN Code
- W02029001 ERYTHROCYTE SEDIMENTATION RATE DEVICES EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
iSED PRO by Alcor Scientific — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 0850028040iSEDPROLT | Class A | Active |
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Manufacturer
- Manufacturer
- Alcor Scientific
- EUDAMED SRN
- US-MF-000029295
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 45fd1236-20d9-4bfc-b022-878f8d50bf1d 61 fields · synced Jun 18, 2026