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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 extra, size 1 — Class I MDR

MD Atlas
Eduard Gerlach GmbH

EUDAMED last updated this device on May 29, 2026

NASPAN PLATINUM BRACE extra, size 1

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: 363382011
Reference / catalog number: 363382011

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View device family (Basic UDI)

Manufacturer information

Organization name: Eduard Gerlach GmbH
SRN: DE-MF-000006590
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.

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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 extra, size 1
UDI-DI code: 363382011
Basic UDI-DI: PP09450.NASPAN.SPANGE.K42
Reference / catalog number: 363382011
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

363382011

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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Related devices

NASPAN PLATINUM BRACE small size 1PP09450.NASPAN.SPANGE.K42On the market NASPAN PLATINUM BRACE small size 2PP09450.NASPAN.SPANGE.K42On the market NASPAN PLATINUM BRACE small size 3PP09450.NASPAN.SPANGE.K42On the market NASPAN PLATINUM BRACE small size 4PP09450.NASPAN.SPANGE.K42On the market NASPAN PLATINUM BRACE small size 5PP09450.NASPAN.SPANGE.K42On 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.