Identity
- Trade Name
- Dako CoverStainer EUDAMEDFDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- Dako CoverStainer EUDAMEDFDA UDI
- Model / Reference
- CS100 EUDAMEDFDA UDICS10030 EUDAMED
- Description
- Dako CoverStainer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571112571 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057P3007P3010A052101N4 EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202059002 AUTOMATED SLIDE STAINERS EUDAMED
- GMDN Term
- Microscope slide stainer IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3800 FDA UDI
- Market of Registration
- Denmark 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
Dimensions & Sizes
- Size
- Weight — 105000 Gram FDA UDI
Category: Microscope slide stainer IVD
Dako CoverStainer by Agilent Technologies Singapore Pte Ltd — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Singapore Pte Ltd
Sources (2)
- FDA UDI 59fb18db-21e5-4666-baa8-7c58a07f1ed8 35 fields · synced Jun 19, 2026
- EUDAMED 6e16af77-e95e-4cb7-bcfe-38148c5b1159 61 fields · synced Jun 19, 2026