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CS500 Glass Coverslipper
EUDAMEDFDA UDIClass A (EU MDR)
Ref 130.009.001-00Model CS500
Identity
- Trade Name
- CS500 Glass Coverslipper EUDAMEDFDA UDI
- Generic Name
- Microscope slide coverslipper IVD FDA UDI
- Device Name
- Glass Coverslipper EUDAMED
- Model / Reference
- CS500 EUDAMEDFDA UDI130.009.001-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971182570190 EUDAMEDFDA UDI
- Basic UDI-DI
- 69711825708VY EUDAMED
- Direct Marketing DI
- 06971182570190 EUDAMED
- FDA Product Code
- KIM FDA UDI
- EMDN Code
- W02039004 AUTOMATED SLIDE PREPARATION UNITS EUDAMED
- GMDN Term
- Microscope slide coverslipper IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3400 FDA UDI
- Market of Registration
- Austria 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
CS500 Glass Coverslipper by Dakewe (Shenzhen) Medical Equipment Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 69711825708VY | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Dakewe (Shenzhen) Medical Equipment Co., Ltd.
- EUDAMED SRN
- CN-MF-000009696
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 3ef67dba-7fe7-44b7-a7d7-6c36d06763e8 61 fields · synced Jun 18, 2026
- FDA UDI 2b870dc1-9f54-4933-ac05-9a295cd999af 32 fields · synced May 30, 2026