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20% Tween 20
EUDAMEDFDA UDIClass A (EU MDR)
Ref TWN20НModel TWN20H Ref TWN20LModel Wash Buffers for IHC
Identity
- Trade Name
- 20% Tween 20 EUDAMEDFDA UDI
- Generic Name
- Immunohistochemistry wash buffer reagent IVD FDA UDI
- Device Name
- 20% Tween 20 EUDAMEDWash Buffers for IHC EUDAMED
- Model / Reference
- TWN20H EUDAMEDFDA UDITWN20Н EUDAMEDTWN20L EUDAMEDFDA UDIWash Buffers for IHC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00847627014665 EUDAMEDFDA UDI00847627014672 EUDAMEDFDA UDI
- Basic UDI-DI
- 08476270BWASHBUF3Q EUDAMED
- FDA Product Code
- JCC FDA UDI
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
- GMDN Term
- Immunohistochemistry wash buffer reagent IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- Hungary EUDAMEDSweden 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
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
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
20% Tween 20 by Biocare Medical — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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 | 08476270BWASHBUF3Q | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Biocare Medical
- EUDAMED SRN
- US-MF-000034581
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (5)
- EUDAMED 45cbc84a-04ed-4d64-b160-c027ecbe56da 61 fields · synced Jul 31, 2026
- FDA UDI 7887199e-b748-4003-89bd-a2becec596b1 33 fields · synced May 29, 2026
- FDA UDI f6ddbad0-0493-4c87-af90-44fb1dead5f2 33 fields · synced May 30, 2026
- EUDAMED 126a90d0-811c-4474-aec8-ad14533a8ef0 61 fields · synced Jul 16, 2026
- EUDAMED d936895e-d3c7-49fe-80a4-0541919c83f7 61 fields · synced Jul 31, 2026