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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

NR03-XHGF-SM-01 — Class IIa MDR by Speed Care Mineral GmbH

MD Atlas
Speed Care Mineral GmbH

EUDAMED last updated this device on Feb 12, 2026

NR03-XHGF-SM-01

426237786SCM001AT

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Speed Care Mineral GmbH
UDI-DI code: 04262377860144
Reference / catalog number: NR03-XHGF-SM-01

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View device family (Basic UDI)

Manufacturer information

Organization name: Speed Care Mineral GmbH
SRN: DE-MF-000020226
Manufacturer status: Active

Critical warnings

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

CW032
EUDAMED did not publish a description for this code.
CW999
SpeedM® is not indicated for use on the eyeball as there may be a risk of dehydration or pressure damage. The product is not indicated for use in or in direct contact with the central circulatory system. SpeedM® must not be used in patients with a known allergic reaction to clay minerals.
CW007
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	May 27, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 04262377860144
Basic UDI-DI: 426237786SCM001AT
Reference / catalog number: NR03-XHGF-SM-01
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Sterile hemostatic dressing with HNT-mineral
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 7.5 MU10
370 MU10

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

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

M040599HAEMOSTATIC DRESSINGS - OTHER

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

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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.