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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

50001 — Class I MDR by Perfood GmbH

MD Atlas
Perfood GmbH

EUDAMED last updated this device on Feb 6, 2024

50001

4260583794260583790132HN

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Perfood GmbH
UDI-DI code: 04260583790132
Reference / catalog number: 50001

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Manufacturer information

Organization name: Perfood GmbH
SRN: DE-MF-000018844
Manufacturer status: Active

Critical warnings

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

CW010
Contraindication: Diabetes mellitus Type 2

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: 04260583790132
Basic UDI-DI: 4260583794260583790132HN
Reference / catalog number: 50001
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: sinCephalea by Perfood GmbH is a software-based medical device for supportive care in the therapy of migraine according to the diagnostics code ICD-10 Code G43.- and Class 1 of IHS Classification ICHD-3, respectively. The product aims at modulating the postprandial blood glucose responses of an individual with personalized nutrition.
Additional information URL: https://www.sincephalea.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

V92MEDICAL DEVICE SOFTWARE - 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

ebby4260583794260583790132HNOn the market 500024260583794260583790002H8On 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.