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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

TPN-07-20-12-C8 — Class IIa MDD by SGM d.o.o.

MD Atlas
SGM d.o.o.

EUDAMED last updated this device on May 22, 2024

TPN-07-20-12-C8

B-03859894113443

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: SGM d.o.o.
UDI-DI code: 03859894113443
Reference / catalog number: TPN-07-20-12-C8

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Manufacturer information

Organization name: SGM d.o.o.
SRN: HR-MF-000029379
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.

CW007
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 03859894113443
Basic UDI-DI: B-03859894113443
Reference / catalog number: TPN-07-20-12-C8
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Needle electrode twisted pair; 0.35 mm (28G)x07 mm stainless steel; lancet; 2,0 m cable; female connector DIN 42802
Additional information URL: https://www.sgm.hr/products/iom-electrodes-1/item/5-twisted-paired
Clinical sizes: 7 MU50

EMDN nomenclature code(s)

N010101ELECTROMYOGRAPHIC ELECTRODES

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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