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Phosphate Buffered Saline plus Tween 20 (20x) pH 7.6 500 mL

EUDAMED

Class A (EU MDR)

Ref PBT500Ref PBT999Ref PBT-20000

by ScyTek Laboratories Inc.

Identity

Trade Name
Phosphate Buffered Saline plus Tween 20 (20x) pH 7.6 500 mL EUDAMED
Phosphate Buffered Saline plus Tween 20 (20x) pH 7.6 1000 mL EUDAMED
Phosphate Buffered Saline plus Tween 20 (20x) pH 7.6 20 L EUDAMED
Device Name
Histology Reagents - Other EUDAMED
Model / Reference
PBT500 EUDAMED
PBT999 EUDAMED
PBT-20000 EUDAMED

Identifiers

Primary DI / UDI-DI
00810108717508 EUDAMED
00810108717515 EUDAMED
00810108717492 EUDAMED
Basic UDI-DI
081010871W01030799GD EUDAMED
Direct Marketing DI
00810108717508 EUDAMED
00810108717515 EUDAMED
00810108717492 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

Phosphate Buffered Saline plus Tween 20 (20x) pH 7.6 500 mL by ScyTek Laboratories Inc. — Class A — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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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 4444f789-ff8c-4505-8e53-74b1667e391f 61 fields · synced Jul 12, 2026
  • EUDAMED 80370cd9-ef91-44cf-86d1-0a8e6b7527a9 61 fields · synced May 17, 2026
  • EUDAMED 6cea0132-833d-4d02-bb1d-37fe5b035145 61 fields · synced May 17, 2026