← Back to catalogue
Papanicoiau Stain
EUDAMEDClass A (EU MDR)
Ref GKPD013Model Hematoxylin Staining Solution 75ml ，EA/OG Staining 75ml（100ml、125ml、200ml、250ml、500ml、1000ml）
Identity
- Trade Name
- Papanicoiau Stain EUDAMED
- Device Name
- Papanicoiau Stain EUDAMED
- Model / Reference
- Hematoxylin Staining Solution 75ml ，EA/OG Staining 75ml（100ml、125ml、200ml、250ml、500ml、1000ml） EUDAMEDGKPD013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698400228 EUDAMED
- Basic UDI-DI
- 697769840GKPD01368 EUDAMED
- EMDN Code
- W01019099 CLINICAL CHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Spain 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
Yes
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
The Papanicoiau Stain is a hematoxylin staining solution used for staining tissue samples, providing accurate and detailed observations. Developed by Dezhou Guoke Medical Technology Co., Ltd., this device is designed to ensure high-quality results in various medical applications.
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 | 697769840GKPD01368 | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dezhou Guoke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044128
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED 0583176e-523e-45f7-8aed-b6be7fead12c 61 fields · synced Oct 6, 2026