← Back to catalogue
Eosin Staining Solution
EUDAMEDFDA UDIClass A (EU MDR)
Ref 4960221Model Alcohol-soluble; Water-soluble
Identity
- Trade Name
- BioSci™ FDA UDI
- Generic Name
- Biological stain IVD FDA UDI
- Device Name
- Eosin Staining Solution EUDAMEDFDA UDI
- Model / Reference
- Alcohol-soluble; Water-soluble EUDAMED4960221 EUDAMEDWater-soluble FDA UDI
- Description
- Eosin Staining Solution FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973471960668 EUDAMEDFDA UDI
- Basic UDI-DI
- 697347196496HEE9E EUDAMED
- FDA Product Code
- HYB FDA UDI
- EMDN Code
- W01030708 STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY) EUDAMED
- GMDN Term
- Biological stain IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.1850 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
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
Eosin Staining Solution by Shenzhen Dakewe Bio-Engineering Co., Ltd. — 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 | 697347196496HEE9E | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Dakewe Bio-engineering Co., Ltd.
- EUDAMED SRN
- CN-MF-000002174
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED fa730df9-732f-4232-bd20-12bfede943ba 61 fields · synced Jun 17, 2026
- FDA UDI 50da2da2-9b4f-4c33-9f43-44cabbecef78 33 fields · synced May 30, 2026