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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

IS-HELICO-01 — Class IIb MDD by APIS Technologies

MD Atlas
APIS Technologies

EUDAMED last updated this device on Apr 8, 2026

IS-HELICO-01

B-03760151650192

On the marketClass IIb

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: APIS Technologies
UDI-DI code: 03760151650192
Reference / catalog number: IS-HELICO-01

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Manufacturer information

Organization name: APIS Technologies
SRN: CH-MF-000039694
Manufacturer status: Active

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Sep 1, 2002	Apr 8, 2026

Device identification

Trade name: not provided
UDI-DI code: 03760151650192
Basic UDI-DI: B-03760151650192
Reference / catalog number: IS-HELICO-01
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U070101SLING SYSTEMS FOR THE TREATMENT OF INCONTINENCE

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

IS-M-1B-03760151650185On the market IS-11-ROB-03760151650109On the market IS-6B-03760151650055On the market IS-TOTB-03760151650680On the market IS-RPUB-03760151650710On 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.