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Organization name
UDI-DI code
Reference / catalog number

KRE:0164S — Class I MDR by Kreienbaum Neoscience…

MD Atlas
Kreienbaum Neoscience GmbH

EUDAMED last updated this device on May 21, 2024

KRE:0164S

426064289CPAPN95

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Kreienbaum Neoscience GmbH
UDI-DI code: 14260642890015
Reference / catalog number: KRE:0164S

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Manufacturer information

Organization name: Kreienbaum Neoscience GmbH
SRN: DE-MF-000004937
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.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 2 countries total.

Country	On market since	Until
GermanyPrimary placement	May 17, 2024	Still on market
Poland	May 17, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 14260642890015
Basic UDI-DI: 426064289CPAPN95
Reference / catalog number: KRE:0164S
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: 20
Additional product description: Hydrocolloid-based nasal plaster
Additional information URL: https://www.kreienbaum-neo.de/medizintechnik/cpapnose/
Clinical sizes: Small

EMDN nomenclature code(s)

M0599MEDICAL PLASTERS - 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

KRE.0165L426064289CPAPN95On 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.