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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

NASPAN PLATINUM BRACE small size 2 — Class I MDR

MD Atlas
Eduard Gerlach GmbH

EUDAMED last updated this device on May 28, 2026

NASPAN PLATINUM BRACE small size 2

PP09450.NASPAN.SPANGE.K42

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Eduard Gerlach GmbH
UDI-DI code: 363384022
Reference / catalog number: 363384022

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Manufacturer information

Organization name: Eduard Gerlach GmbH
SRN: DE-MF-000006590
Manufacturer status: Active

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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: NASPAN PLATINUM BRACE small size 2
UDI-DI code: 363384022
Basic UDI-DI: PP09450.NASPAN.SPANGE.K42
Reference / catalog number: 363384022
Issuing entity: IFA

Classification

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

Device details

Quantity: 5
Additional product description: Self-regulating, one-piece orthonyxia brace for the treatment of curled and ingrown toenails.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

363384022

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Y061299LOWER EXTREMITY ORTHOSES - 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

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