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NS40 Fully Automated IHC Stainer
EUDAMEDFDA UDIClass A (EU MDR)
Ref 130.031.001-00Model NS40, NS20
Identity
- Trade Name
- NS40 Fully Automated IHC Stainer EUDAMEDFully Automated IHC Stainer FDA UDI
- Generic Name
- Microscope slide stainer IVD FDA UDI
- Device Name
- Fully Automated IHC Stainer EUDAMED
- Model / Reference
- NS40, NS20 EUDAMED130.031.001-00 EUDAMEDNS40 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971182571326 EUDAMEDFDA UDI
- Basic UDI-DI
- 69711825725VY EUDAMED
- Direct Marketing DI
- 06971182571326 EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202059001 IMMUNOHISTOCHEMISTRY PROCESSORS EUDAMED
- GMDN Term
- Microscope slide stainer IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3800 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
NS40 Fully Automated IHC Stainer by Dakewe (Shenzhen) Medical Equipment Co., Ltd. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 69711825725VY | 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 (2)
- EUDAMED a631535d-8388-459e-890a-c909422d31e1 61 fields · synced Jul 9, 2026
- FDA UDI 0f2092dd-e1d5-484d-852f-af698a126460 32 fields · synced May 30, 2026