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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

NGM WAVE Expansion Handle — Class I MDR by NGMedical GmbH

MD Atlas
NGMedical GmbH

EUDAMED last updated this device on Nov 25, 2025

NGM WAVE Expansion Handle

42516314TD012I49

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: NGMedical GmbH
UDI-DI code: 04251631408666
Reference / catalog number: I305

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Manufacturer information

Organization name: NGMedical GmbH
SRN: DE-MF-000000204
Manufacturer status: Active

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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

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

CW010
EUDAMED did not publish a description for this code.
CW036
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		Still on market
Ireland		Still on market

Device identification

Trade name: NGM WAVE Expansion Handle
UDI-DI code: 04251631408666
Basic UDI-DI: 42516314TD012I49
Reference / catalog number: I305
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: The instruments of class Ir are reusable surgical instruments with the purpose of enabling the implantation of an implant of NGMedical. The surgical technique of each implant describes the instruments to be used in each case.
Additional information URL: https://ngmedical.de/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L091099OSTEOSYNTHESIS INSTRUMENTS, REUSABLE - 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

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Software identification