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Microscope Cover Galss
EUDAMEDFDA UDIClass A (EU MDR)
Ref 030.009.011-00Model 030.009.019-00, 030.009.011-00Ref 030.009.019-00
Identity
- Trade Name
- Microscope Cover Galss EUDAMEDMicroscope Cover Glass FDA UDI
- Generic Name
- Microscope slide coverslip IVD FDA UDI
- Device Name
- Microscope Cover Galss EUDAMED
- Model / Reference
- 030.009.019-00, 030.009.011-00 EUDAMED030.009.011-00 EUDAMEDFDA UDI030.009.019-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971182571241 EUDAMEDFDA UDI06971182571234 EUDAMED
- Basic UDI-DI
- 69711825719W5 EUDAMED
- FDA Product Code
- KES FDA UDI
- EMDN Code
- W0503900202 MICROSCOPE SLIDES COVERSLIP EUDAMED
- GMDN Term
- Microscope slide coverslip IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3010 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Microscope Cover Galss by Dakewe (Shenzhen) Medical Equipment 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 | 69711825719W5 | 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
- SUNGO Europe B.V. NL-AR-000000247
Sources (3)
- EUDAMED 3a3c7a09-2966-4446-88f0-cd370c522751 61 fields · synced Oct 6, 2026
- EUDAMED 2883ca2e-5044-4ea1-87bf-03393393659c 61 fields · synced May 17, 2026
- FDA UDI e283e9ae-628f-46e2-b816-189ad70944b9 32 fields · synced May 30, 2026