EUDAMED last updated this device on May 28, 2026

004 711

5904553993041PYQ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MARGOMED SPÓŁKA AKCYJNA
UDI-DI code: 05905386929127
Reference / catalog number: 004 711

004 711 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by MARGOMED SPÓŁKA AKCYJNA . Placed on the EU market in Poland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Role
Country
Date of registration
Address

EUDAMED last updated this device on May 28, 2026

004 711

5904553993041PYQ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MARGOMED SPÓŁKA AKCYJNA
UDI-DI code: 05905386929127
Reference / catalog number: 004 711

View device family (Basic UDI)

Device identification

Trade name: not provided
UDI-DI code: 05905386929127
Basic UDI-DI: 5904553993041PYQ
Reference / catalog number: 004 711
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)05905386929127

UDI-PI DataMatrix

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

EMDN nomenclature code(s)

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

A03020199EXTENSIONS - OTHER

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

Market distribution

Primary placement in Poland; available across 28 countries total.

Country	On market since	Until
PolandPrimary placement	Apr 25, 2025	Still on market
Austria	Apr 25, 2025	Still on market
Belgium	Apr 25, 2025	Still on market
Bulgaria	Apr 25, 2025	Still on market
Cyprus	Apr 25, 2025	Still on market
Czechia	Apr 25, 2025	Still on market
Germany	Apr 25, 2025	Still on market
Denmark	Apr 25, 2025	Still on market
Estonia	Apr 25, 2025	Still on market
EL	Apr 25, 2025	Still on market
Spain	Apr 25, 2025	Still on market
Finland	Apr 25, 2025	Still on market
France	Apr 25, 2025	Still on market
Croatia	Apr 25, 2025	Still on market
Hungary	Apr 25, 2025	Still on market
Ireland	Apr 25, 2025	Still on market
Italy	Apr 25, 2025	Still on market
Lithuania	Apr 25, 2025	Still on market
Luxembourg	Apr 25, 2025	Still on market
Latvia	Apr 25, 2025	Still on market
Malta	Apr 25, 2025	Still on market
Netherlands	Apr 25, 2025	Still on market
Norway	Apr 25, 2025	Still on market
Portugal	Apr 25, 2025	Still on market
Romania	Apr 25, 2025	Still on market
Sweden	Apr 25, 2025	Still on market
Slovenia	Apr 25, 2025	Still on market
Slovakia	Apr 25, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 05905386929127
Basic UDI-DI: 5904553993041PYQ
Reference / catalog number: 004 711
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.

Manufacturer information

Organization name: MARGOMED SPÓŁKA AKCYJNA
SRN: PL-MF-000009261
Manufacturer status: Active

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05905386929127

UDI-PI DataMatrix

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

EMDN nomenclature code(s)

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

A03020199EXTENSIONS - OTHER

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

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

Certificates

Certificate health across this manufacturer's portfolio.

HZ 2631342-1Issued
Quality management systemNotified body: 0197Expiry: Apr 24, 2030

Certificates covering this device

No certificate specifically references this device's Basic UDI-DI.

All products by MARGOMED SPÓŁKA AKCYJNA

Market distribution

Primary placement in Poland; available across 28 countries total.

Country	On market since	Until
PolandPrimary placement	Apr 25, 2025	Still on market
Austria	Apr 25, 2025	Still on market
Belgium	Apr 25, 2025	Still on market
Bulgaria	Apr 25, 2025	Still on market
Cyprus	Apr 25, 2025	Still on market
Czechia	Apr 25, 2025	Still on market
Germany	Apr 25, 2025	Still on market
Denmark	Apr 25, 2025	Still on market
Estonia	Apr 25, 2025	Still on market
EL	Apr 25, 2025	Still on market
Spain	Apr 25, 2025	Still on market
Finland	Apr 25, 2025	Still on market
France	Apr 25, 2025	Still on market
Croatia	Apr 25, 2025	Still on market
Hungary	Apr 25, 2025	Still on market
Ireland	Apr 25, 2025	Still on market
Italy	Apr 25, 2025	Still on market
Lithuania	Apr 25, 2025	Still on market
Luxembourg	Apr 25, 2025	Still on market
Latvia	Apr 25, 2025	Still on market
Malta	Apr 25, 2025	Still on market
Netherlands	Apr 25, 2025	Still on market
Norway	Apr 25, 2025	Still on market
Portugal	Apr 25, 2025	Still on market
Romania	Apr 25, 2025	Still on market
Sweden	Apr 25, 2025	Still on market
Slovenia	Apr 25, 2025	Still on market
Slovakia	Apr 25, 2025	Still on market

004 711

004 711

Device identification

Classification

Device details

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates covering this device

Market distribution

Related searches

Device identification

Classification

Device details

Manufacturer information

UDI-PI traceability

UDI-DI DataMatrix

UDI-PI DataMatrix

EMDN nomenclature code(s)

Critical warnings

Compliance flags

Safety

Substances

Regulatory

Lifecycle

Certificates

Certificates covering this device

Related devices

Market distribution

Related searches

Manufacturer information

Certificates

Related devices