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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

HM-HVB-SMIIR-C-01 — Class I MDR by HEIQ MEDICA, S.L.

MD Atlas
HEIQ MEDICA, S.L.

EUDAMED last updated this device on Dec 13, 2021

HM-HVB-SMIIR-C-01

843659865001LQ

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HEIQ MEDICA, S.L.
UDI-DI code: 08436598650044
Reference / catalog number: HM-HVB-SMIIR-C-01

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Manufacturer information

Organization name: HEIQ MEDICA, S.L.
SRN: ES-MF-000001346
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW011
Not suitable for children under 3 years

Market distribution

Primary placement in Spain; available across 1 country total.

Placed on the market in Spain; per-country availability dates not published.

Device identification

Trade name: not provided
UDI-DI code: 08436598650044
Basic UDI-DI: 843659865001LQ
Reference / catalog number: HM-HVB-SMIIR-C-01
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: Mascarilla quirúrgica tipo IIR HeiQ MetalliQ Combix 10 ud
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

T020604MEDICAL USE FACE MASKS, TYPE II AND IIR

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

Masque chirurgical type IIR HeiQ MetalliQ HM-HVB-SMIIR-C-01 30 Ud843659865001LQOn the market HM-HVB-SMIIR-A-01843659865001LQOn the market Masque chirurgical type IIR HeiQ Viroblock HM-HVB-SMIIR-A-01 50 Ud843659865001LQOn the market Surgical mask type IIR HeiQ MetalliQ HM-HVB-SMIIR-C-01 30 Ud843659865001LQOn 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.