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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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ISOTONIC SEA WATER EAR SPRAY — 8 UDI-DI variants, MDR

MD Atlas
STE PHARMACEUTICALS, S.L.U

Data from EUDAMED, last updated May 23, 2026

ISOTONIC SEA WATER EAR SPRAY

843654262PL00278S

8 UDI-DI variants

MDR [Regulation (EU) 2017/745 on medical devices]Class IIa

Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Manufacturer: STE PHARMACEUTICALS, S.L.U

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Device characteristics

No device characteristics flagged

Identity & classification

Basic UDI-DI: 843654262PL00278S
Device name: ISOTONIC SEA WATER EAR SPRAY
Issuing agency: GS1
Legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Risk class: Class IIa
Version date: Apr 28, 2026

Manufacturer & authorised representative

Manufacturer

Name: STE PHARMACEUTICALS, S.L.U
SRN: ES-MF-000000144
Country: Spain
Email: ihernandez@stepharmaceuticals.com
Phone: +34 935923100

Variants by status

UDI-DI variants

8 UDI-DI variants

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Applied filters

basicUdiUlid01KQ9Q8GV7CVP31G83A4XP2KRA

Format

Summary

29 columns included

Trade name
Basic UDI-DI
UDI-DI code
Risk category
Applicable legislation
Status
Organization name
SRN
Reference / catalog number
Additional product description
Intended medical purpose
Placed on the market (country)
Market info update date
Sterile
Single use
Contains latex
Reprocessed single-use
Direct marking
CMR substance
Endocrine disruptor
Annex XVI applicable
Sterilization
OEM applicable
EMDN codes
Last updated
Basic UDI-DI device name
Basic UDI-DI device model
Basic UDI-DI implantable
Basic UDI-DI reagent

PL0027_3008436542625456
PL0027_100_Soft08436542627146
PL0027_3005202888109416
PL0027_3008435232362916
PL0027_3008430469231998
PL0027_3008436617644269
PL0027_3008436542623636
PL0027_100_Soft08436542627153