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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

M040HU — Class IIa MDR by Serrix B.V

MD Atlas
Serrix B.V

EUDAMED last updated this device on Mar 27, 2026

M040HU

871830970M0X0EGC8

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Serrix B.V
UDI-DI code: 08718309702687
Reference / catalog number: M040HU

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View device family (Basic UDI)

Manufacturer information

Organization name: Serrix B.V
SRN: NL-MF-000005882
Manufacturer status: Active

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Certificates

Certificate health across this manufacturer's portfolio.

BE23/00000172Supplemented
Quality management systemNotified body: 1639Expiry: Jun 19, 2028

Critical warnings

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

CW275
When pregnant or breastfeeding, only use if instructed by and under supervision of a health care professional
CW010
Consult instruction for use (symbol)
CW262
Single patient, multiple use (symbol)

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Market distribution

Primary placement in Hungary; available across 1 country total.

Country	On market since	Until
HungaryPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08718309702687
Basic UDI-DI: 871830970M0X0EGC8
Reference / catalog number: M040HU
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: —
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

Encoded

(01)08718309702687

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - 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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