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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

IV12-00 — Class I MDR by Ivalmed S.L.

MD Atlas
Ivalmed S.L.

EUDAMED last updated this device on Apr 23, 2026

IV12-00

84357608INSIMPACTOPE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Ivalmed S.L.
UDI-DI code: 08435760808344
Reference / catalog number: IV12-00

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Manufacturer information

Organization name: Ivalmed S.L.
SRN: ES-MF-000000634
Manufacturer status: Active

Related devices

IV780-5584357608ADAPTADORESRNOn the market IV780-9084357608ADAPTADORESRNOn the market IV784-77-0084357608ADAPTADORESRNOn the market IV784-78-0084357608ADAPTADORESRNOn the market IV784-10-0084357608ADAPTADORESRNOn 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.

Market distribution

Primary placement in Spain; available across 1 country total.

Country	On market since	Until
SpainPrimary placement	Apr 23, 2026	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08435760808344
Basic UDI-DI: 84357608INSIMPACTOPE
Reference / catalog number: IV12-00
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: Instrumento contundente, cuyo principal fin es el de impactar o extraer otro instrumento. Cuenta con cuperpo robusto para aguantar las fuerzas de impacto a las que está expuesto
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

L0399GENERAL SURGERY 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification