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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

RES001/KCL001NEW/KIMP001NEW/KIMP00… — Class I MDR

MD Atlas
DENTALSUR2003 S.L.

EUDAMED last updated this device on Dec 22, 2023

RES001/KCL001NEW/KIMP001NEW/KIMP002NEW/KDJ035/KTE001NEW

84353304KCLI001EB

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: DENTALSUR2003 S.L.
UDI-DI code: 84353304KCL0MK
Reference / catalog number: RES001/KCL001NEW/KIMP001NEW/KIMP002NEW/KDJ035/KTE001NEW

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Manufacturer information

Organization name: DENTALSUR2003 S.L.
SRN: ES-MF-000039218
Manufacturer status: Active

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: 84353304KCL0MK
Basic UDI-DI: 84353304KCLI001EB
Reference / catalog number: RES001/KCL001NEW/KIMP001NEW/KIMP002NEW/KDJ035/KTE001NEW
Issuing entity: HIBCC

Classification

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

Device details

Quantity: 6
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)

Q0102050101TEMPORARY TEETH RESINS

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

PRORES00184353304PROCSEOn 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.