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Acid Fast stain(Ziehl-Neelsen)
EUDAMEDClass A (EU MDR)
Ref GKPD014Model Compound Red Staining Solution 20ml, decolorizing solution20ml, methylene blue dye solution 20ml(100ml\200ml\250ml\450ml\500ml\1000ml\5000ml)
Identity
- Trade Name
- Acid Fast stain(Ziehl-Neelsen) EUDAMED
- Device Name
- Acid Fast stain(Ziehl-Neelsen) EUDAMED
- Model / Reference
- Compound Red Staining Solution 20ml, decolorizing solution20ml, methylene blue dye solution 20ml(100ml\200ml\250ml\450ml\500ml\1000ml\5000ml) EUDAMEDGKPD014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977698400211 EUDAMED
- Basic UDI-DI
- 697769840GKPD0146A 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
Category: Nucleic acid extraction/isolation kit IVD
Acid Fast stain(Ziehl-Neelsen) by Dezhou Guoke Medical Technology Co., Ltd. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nucleic acid extraction/isolation kit IVD.
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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 | 697769840GKPD0146A | Class A | Active |
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Manufacturer
- Manufacturer
- Dezhou Guoke Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000044128
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (1)
- EUDAMED ca086201-4bb5-4974-9a3d-391b96cfdb53 61 fields · synced Jul 15, 2026