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Organization name
UDI-DI code
Reference / catalog number

SOPHY® SM1A-H KIT PREATTACHED /… — Class III MDD by SOPHYSA

MD Atlas
SOPHYSA

EUDAMED last updated this device on Feb 20, 2026

SOPHY® SM1A-H KIT PREATTACHED / BO19-10

B-03760124131901

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: SOPHYSA
UDI-DI code: 03760124131901
Reference / catalog number: SM1A-2010H

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Manufacturer information

Organization name: SOPHYSA
SRN: FR-MF-000002870
Manufacturer status: Active

Critical warnings

3 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.
CW001
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Croatia; available across 2 countries total.

Country	On market since	Until
CroatiaPrimary placement	Sep 1, 2015	Still on market
Poland	Mar 1, 2021	Still on market

Device identification

Trade name: SOPHY® SM1A-H KIT PREATTACHED / BO19-10
UDI-DI code: 03760124131901
Basic UDI-DI: B-03760124131901
Reference / catalog number: SM1A-2010H
Issuing entity: GS1

Classification

Risk category: Class III
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Monopressure Valve for CSF Shunting, with catheters. Radiopaque. Non-pyrogenic. Check packaging integrity before use.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

N01038099INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - 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

SOPHY® SM1-M KIT PREATTACHED/ BO19-10B-03760124130980On the market CATHETER EXTENSION CABLE376012413PSOEC30000F6On the market CSF MONITORING AND DRAINAGE SYSTEMB-03760124130263On the market DISPOSABLE HAND DRILLB-03760124131581On the market DISTAL ATRIAL/ PERITONEAL CATHETERB-03760124130010On 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.