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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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ChitoCare Medical Wound Healing Gel — 1 UDI-DI variant, MDD

MD Atlas
Primex ehf

Data from EUDAMED, last updated May 31, 2026

ChitoCare Medical Wound Healing Gel

B-84300-82754J

1 UDI-DI variant

MDD [Directive 93/42/EEC on medical devices]Class III

Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Manufacturer: Primex ehf

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Device characteristics

Animal tissues / cells

Clinical investigations

Registered: No

Legacy certificates

Certificate number: 5-916-204-2104
Type: refdata.legacy.mdd-certificate-type.ii-excluding-4
Notified body: NEOEMKI Nemzeti Orvostechnikai Eszköz Megfelelőségértékelő és Tanúsító Korlátolt Felelősségű Társaság (NEOEMKI LLC) (1011)
Validity: May 26, 2024

Identity & classification

Basic UDI-DI: B-84300-82754J
Device name: ChitoCare Medical Wound Healing Gel
Issuing agency: EUDAMED
Legislation: MDD [Directive 93/42/EEC on medical devices]
Risk class: Class III
Version date: May 26, 2026

Manufacturer & authorised representative

Manufacturer

Name: Primex ehf
SRN: IS-MF-000003735
Country: Iceland
Email: medical@chitocare.is
Phone: +354 460 6900

Variants by status

UDI-DI variants

1 UDI-DI variant

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basicUdiUlid01KSHTB0CHAAHK1CGXPCRN95XG

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

ChitoCare Medical Wound Healing GelD-84300-82754J