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Stain Solutions - EUDAMED Registration 00810108719731

Access comprehensive regulatory information for Stain Solutions in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 00810108719731 and manufactured by ScyTek Laboratories Inc. in United States.

This page provides complete registration details including trade name (Potassium Hydroxide Solution (10%) 15 mL), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.

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EUDAMED Official Data
Class A
00810108719731
No
Stain Solutions
Trade Name: Potassium Hydroxide Solution (10%) 15 mL
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Device Description (EMDN)

STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W01030708
Trade Name
Potassium Hydroxide Solution (10%) 15 mL
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00810108719731
Basic UDI
081010871W01030708FG
Version Date
May 06, 2024
Manufacturer Last Update
May 13, 2022
Active Status
No
Manufacturer
Manufacturer Name
ScyTek Laboratories Inc.
Country
United States
Country Type
NON_EU
Address
205s 600w Logan
Email
scytek@scytek.com
Authorized Representative
SRN
NL-AR-000000116
Country
Netherlands
Address
60 Westervoortsedijk Arnhem
Email
lst.aus.euauthrep@ul.com
Telephone
+31 70 345 8570
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Netherlands
Device Characteristics
Human Tissues
No
Animal Tissues
No