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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

100003IST-3 — Class IIa MDR by ASSKEA GmbH

MD Atlas
ASSKEA GmbH

EUDAMED last updated this device on Feb 27, 2026

100003IST-3

426058604SecretAspDN

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: ASSKEA GmbH
UDI-DI code: 04260586042405
Reference / catalog number: 100003IST-3

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Manufacturer information

Organization name: ASSKEA GmbH
SRN: DE-MF-000005146
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260586042405
Basic UDI-DI: 426058604SecretAspDN
Reference / catalog number: 100003IST-3
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.

EMDN nomenclature code(s)

Z12159009EQUIPMENT FOR REMOVAL OF SECRETIONS

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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

"Bag" external container (1000 ml)426058604Bag-OneWayYHOn the market 1510216HLRM426058604SecretAspDNOn the market 1510215HLRM426058604SecretAspDNOn the market 1510214HL33426058604CanisterReuseY6On the market 100003VAN-3426058604SecretAspDNOn the market

Certificates

Certificate health across this manufacturer's portfolio.

111138U2Issued
Quality management systemNotified body: 0494Expiry: Mar 8, 2031