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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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Organization name
UDI-DI code
Reference / catalog number

ChitoCare Medical Healing Spray — Class III MDD by Primex ehf

MD Atlas
Primex ehf

EUDAMED last updated this device on May 26, 2026

ChitoCare Medical Healing Spray

B-84500-830558

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Primex ehf
UDI-DI code: D-84500-830558
Reference / catalog number: 84500-8305

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View device family (Basic UDI)

Manufacturer information

Organization name: Primex ehf
SRN: IS-MF-000003735
Manufacturer status: Active

Critical warnings

3 warnings recorded — scroll inside the panel to see all entries.

CW267
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW083
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Iceland; available across 1 country total.

Country	On market since	Until
IcelandPrimary placement	Apr 20, 2021	Still on market

Device identification

Trade name: ChitoCare Medical Healing Spray
UDI-DI code: D-84500-830558
Basic UDI-DI: B-84500-830558
Reference / catalog number: 84500-8305
Issuing entity: EUDAMED

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 50 MU03

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-84500-830558

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

M04041502DRESSINGS IN SOLUTIONS, EMULSIONS, GELS, POWDERS WITH ANIMAL COMPONENTS

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

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Related devices

Chitocare Medical Scar Healing GelB-84100-83743FOn the market ChitoCare Medical Wound Healing GelB-84300-82754JOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.