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Organization name
UDI-DI code
Reference / catalog number

SI-ZNIS-M — Class IIa MDR by Standard Instruments GmbH

MD Atlas
Standard Instruments GmbH

EUDAMED last updated this device on Apr 9, 2026

SI-ZNIS-M

426018106VRMPA8

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Standard Instruments GmbH
UDI-DI code: 04260181060088
Reference / catalog number: SI-ZNIS-M

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Manufacturer information

Organization name: Standard Instruments GmbH
SRN: DE-MF-000013833
Manufacturer status: Active

Critical warnings

2 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.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 04260181060088
Basic UDI-DI: 426018106VRMPA8
Reference / catalog number: SI-ZNIS-M
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: Katheter (1x pH, 6x IMP) - Länge M
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

G030799GASTROINTESTINAL ENDOSCOPY, DIAGNOSTIC DEVICES - 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

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

SI-ZNID-L426018106VRMPA8On the market SI-ZNIS-L426018106VRMPA8On the market SI-ZNIS-S426018106VRMPA8On the market SI-SNID15426018106VRMPA8On the market SI-SNID05426018106VRMPA8On 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.