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Organization name
UDI-DI code
Reference / catalog number

SPIROVIT SP-1 G2 — Class IIa MDD by SCHILLER AG

MD Atlas
SCHILLER AG

EUDAMED last updated this device on Apr 28, 2026

SPIROVIT SP-1 G2

B-07613365002881

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: SCHILLER AG
UDI-DI code: 07613365002881
Reference / catalog number: 3.911120

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Manufacturer information

Organization name: SCHILLER AG
SRN: CH-MF-000012722
Manufacturer status: Active

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Critical warnings

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

CW011
The device is not for use in or near magnetic resonance imaging equipment.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Mar 5, 2021	Dec 31, 2028

Device identification

Trade name: SPIROVIT SP-1 G2
UDI-DI code: 07613365002881
Basic UDI-DI: B-07613365002881
Reference / catalog number: 3.911120
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: The SPIROVIT SP-1 G2, together with the sensor SpiroScout SP plus, is a stand-alone diagnostic system for basic examination of the lung function. The system is also intended for monitoring the course of diseases and for therapy control during treatment.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12150101CLINICAL/DIAGNOSTIC SPIROMETERS

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

Certificates

Certificate health across this manufacturer's portfolio.

G10 041505 0132Issued
Quality management systemNotified body: 0123Expiry: Nov 11, 2026