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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

AS-SI-H-R35A — Class IIa MDD by VIMAP TECHNOLOGIES, S.L.U

MD Atlas
VIMAP TECHNOLOGIES, S.L.U

EUDAMED last updated this device on Feb 17, 2023

AS-SI-H-R35A

B-08436557390073

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: VIMAP TECHNOLOGIES, S.L.U
UDI-DI code: 08436557390073
Reference / catalog number: AS-SI-H-R35A

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Manufacturer information

Organization name: VIMAP TECHNOLOGIES, S.L.U
SRN: ES-MF-000006481
Manufacturer status: Active

Related devices

AS-3W-H-R35AB-08436557390059On the market AS-3W-H-R35BB-08436557390097On the market AS-3W-R35AB-08436557390004On the market AS-3W-R35A_WSPB-08436557390028On the market AS-3W-Y-R35AB-08436557390011On 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.

Critical warnings

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

CW007
EUDAMED did not publish a description for this code.
CW010
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: 08436557390073
Basic UDI-DI: B-08436557390073
Reference / catalog number: AS-SI-H-R35A
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: Single use non-sterile administration set/disposable for insufflation of the colon and small bowel during Virtual Enteroscopy (Virtual Enteroclysis) procedure. This product (AS-SI-H-R35A), is for use exclusively with CO2 insufflator VMX-1020A of VIMAP TECHNOLOGIES.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

G02060304COLORECTAL INSUFFLATION TUBES

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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Expiration date
Manufacturing date
Serial number
Software identification