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Haemacytometer Deckglas für Zählkammern 22x22x0, 4 mm Marienfeld Superior
EUDAMEDFDA UDIClass A (EU MDR)
Ref 0351000
Identity
- Trade Name
- Haemacytometer Deckglas für Zählkammern 22x22x0,4 mm Marienfeld Superior EUDAMEDMarienfeld Superior FDA UDI
- Generic Name
- Microscope slide coverslip IVD FDA UDI
- Device Name
- Haemocytometer cover glasses for counting chambers EUDAMED
- Model / Reference
- 0351000 EUDAMED22x22 N.4 with ground and polished edges FDA UDI
Identifiers
- Catalog Number
- 0351000 FDA UDI
- Primary DI / UDI-DI
- 04250317300836 EUDAMEDFDA UDI
- Basic UDI-DI
- 4250317304HGMSS3 EUDAMED
- Unit of Use DI
- 04250317376732 EUDAMED
- FDA Product Code
- KES FDA UDI
- EMDN Code
- W02020199 CELL COUNTING INSTRUMENTS - OTHER 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
- Germany 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
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Haemacytometer Deckglas für Zählkammern 22x22x0, 4 mm Marienfeld Superior by Paul Marienfeld GmbH & Co. KG — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA…
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 | 4250317304HGMSS3 | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Paul Marienfeld GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000023724
Sources (2)
- EUDAMED db356b96-cb3e-423b-8570-c9b5f0dae392 61 fields · synced Oct 10, 2026
- FDA UDI ad1b9462-7bc8-4224-97c4-afcac654aafe 33 fields · synced May 30, 2026