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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

PRT0011 — Class III MDD by NovaCutis GmbH

MD Atlas
NovaCutis GmbH

EUDAMED last updated this device on Mar 21, 2025

PRT0011

B-04270002924154

On the marketClass III

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: NovaCutis GmbH
UDI-DI code: 04270002924154
Reference / catalog number: PRT0011

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Manufacturer information

Organization name: NovaCutis GmbH
SRN: DE-MF-000023708
Manufacturer status: Active

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW007
Confirm that the seal on the box has not been broken and sterility has not been compromised.
CW009
Product is for single use only; do not re-use.
CW032
Confirm that the product has not expired
CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Dec 19, 2013	Mar 1, 2025

Device identification

Trade name: not provided
UDI-DI code: 04270002924154
Basic UDI-DI: B-04270002924154
Reference / catalog number: PRT0011
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: Hyaluronic acid dermal filler
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

P900402RESORBABLE FILLING AND RECONSTRUCTION DEVICES

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

PRT0012B-04270002924147On the market PRT0013B-04270002924130On the market Liquidimplant SubCutisB-PRT00113UOn 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.