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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

100058 — Class I MDD by Pregnolia AG

MD Atlas
Pregnolia AG

EUDAMED last updated this device on Aug 19, 2025

100058

B-CHMF000033377PregCUQS

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Pregnolia AG
UDI-DI code: D-CHMF000033377PregCUQS
Reference / catalog number: 100058

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Manufacturer information

Organization name: Pregnolia AG
SRN: CH-MF-000033377
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 Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: D-CHMF000033377PregCUQS
Basic UDI-DI: B-CHMF000033377PregCUQS
Reference / catalog number: 100058
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: https://www.pregnolia.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V030205OBSTETRICS AND GYNECOLOGY MEASUREMENT DEVICES NOT INCLUDED IN OTHER CLASSES

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

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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.