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Tris Buffered Saline plus Tween 20 (20x Concentrate) pH 7.4 1000 mL
EUDAMEDClass A (EU MDR)
Ref TBT999Ref TBT010Ref TBT500
Identity
- Trade Name
- Tris Buffered Saline plus Tween 20 (20x Concentrate) pH 7.4 1000 mL EUDAMEDTris Buffered Saline plus Tween 20 (20x Concentrate) pH 7.4 10 L EUDAMEDTris Buffered Saline plus Tween 20 (20x Concentrate) pH 7.4 500 mL EUDAMED
- Device Name
- Histology Reagents - Other EUDAMED
- Model / Reference
- TBT999 EUDAMEDTBT010 EUDAMEDTBT500 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00810108718765 EUDAMED00810108718741 EUDAMED00810108718758 EUDAMED
- Basic UDI-DI
- 081010871W01030799GD EUDAMED
- Direct Marketing DI
- 00810108718765 EUDAMED00810108718741 EUDAMED00810108718758 EUDAMED
- EMDN Code
- W01030799 HISTOLOGY / CYTOLOGY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
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
Tris Buffered Saline plus Tween 20 (20x Concentrate) pH 7.4 1000 mL by ScyTek Laboratories Inc. — Class A — IVDR — listed in EUDAMED
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 | 081010871W01030799GD | Class A | Active |
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Manufacturer
- Manufacturer
- ScyTek Laboratories Inc.
- EUDAMED SRN
- US-MF-000023816
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED ff750cd2-8015-46af-b743-8a79281c34cf 61 fields · synced Jul 30, 2026
- EUDAMED 9f1aa3e6-0439-439b-81f4-f7d0c40ba9cb 61 fields · synced May 17, 2026
- EUDAMED 236e3580-857b-41e8-8cc8-a210fe4de3b5 61 fields · synced May 18, 2026