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Papanicolaou Stain Modified Ea 65
EUDAMEDClass A (EU MDR)
Ref HT40232-1LModel HT40
Identity
- Trade Name
- PAPANICOLAOU STAIN MODIFIED EA 65 EUDAMED
- Device Name
- PAPANICOLAOU STAINING SYSTEM EUDAMED
- Model / Reference
- HT40 EUDAMEDHT40232-1L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04061838207661 EUDAMED
- Basic UDI-DI
- 040618HT40AQ EUDAMED
- EMDN Code
- W0103010301 HISTO / CYTO STAINS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
Papanicolaou Stain Modified Ea 65 by Sigma-Aldrich Corporation — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 040618HT40AQ | Class A | Active |
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Manufacturer
- Manufacturer
- Sigma-Aldrich Corporation
- EUDAMED SRN
- US-MF-000025162
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 6148d6ec-c257-47d7-b014-db4ec052ce6f 61 fields · synced Jul 15, 2026