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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

VH-97-ERA — Class IIa MDR by Sendal, S.L.

MD Atlas
Sendal, S.L.

EUDAMED last updated this device on Feb 2, 2022

VH-97-ERA

8428820TRANSFUSENDKN

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sendal, S.L.
UDI-DI code: 08428820051354
Reference / catalog number: VH-97-ERA

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Manufacturer information

Organization name: Sendal, S.L.
SRN: ES-MF-000016981
Manufacturer status: Active

Related devices

VH-22-E3VGA8428820TRANSFUSENDKNOn the market VH-27-EA8428820TRANSFUSENDKNOn the market VH-26-EY3VGA8428820TRANSFUSENDKNOn the market VH-338428820TRANSFUSENDKNOn 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.

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
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	Jan 1, 2006	Jan 2, 2023

Device identification

Trade name: not provided
UDI-DI code: 08428820051354
Basic UDI-DI: 8428820TRANSFUSENDKN
Reference / catalog number: VH-97-ERA
Issuing entity: GS1

Classification

Risk category: Class IIa
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: 2-way transfusion set.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

B010201WHOLE BLOOD, RED BLOOD CELLS OR PLASMA TRANSFER BAGS AND KITS

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