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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

DMDDX01 — Class IIb MDD by DEBx Medical BV

MD Atlas
DEBx Medical BV

EUDAMED last updated this device on May 6, 2025

DMDDX01

B-872029960293983

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: DEBx Medical BV
UDI-DI code: D-872029960293983
Reference / catalog number: DMDDX01

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Manufacturer information

Organization name: DEBx Medical BV
SRN: NL-MF-000010908
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW132
EUDAMED did not publish a description for this code.
CW416
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Apr 4, 2025	Dec 31, 2028

Device identification

Trade name: not provided
UDI-DI code: D-872029960293983
Basic UDI-DI: B-872029960293983
Reference / catalog number: DMDDX01
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: Topical dehydrating agent intended for non-surgical debridement and treatment of non-surgical infected wounds applied by healthcare professionals only
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

D-872029960293983

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.

Z12019003WOUND TREATMENT EQUIPMENT

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

DMDD01B-87202996029087QOn the market DMDD02B-08720299602960R9On the market DMDDX02B-87202996029778BOn 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.