Identity
- Trade Name
- EOSIN B SOLUTION FDA UDI
- Generic Name
- Foeto-maternal haemorrhage/Kleihauer test IVD, reagent FDA UDI
- Device Name
- FETAL HEMOGLOBIN EUDAMED
- Model / Reference
- 285 EUDAMED2853-50ML EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04061837279263 EUDAMEDFDA UDI
- Basic UDI-DI
- 040618285K2 EUDAMED
- FDA Product Code
- ICC FDA UDI
- EMDN Code
- W0103010301 HISTO / CYTO STAINS EUDAMED
- GMDN Term
- Foeto-maternal haemorrhage/Kleihauer test IVD, reagent FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1850 FDA UDI
- Market of Registration
- Germany 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
Yes
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
Fetal Hemoglobin by Sigma-Aldrich Corporation — 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 | 040618285K2 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Sigma-Aldrich Corporation
- EUDAMED SRN
- US-MF-000025162
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 0c4cd6b4-e153-4804-a2a0-2b74d668a63c 61 fields · synced Jun 18, 2026
- FDA UDI f77db1d7-d467-4af8-b4e3-627655d87d61 33 fields · synced May 30, 2026