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Organization name
UDI-DI code
Reference / catalog number

S16X10 — Class IIb MDR by EM EXACT, S.A.

MD Atlas
EM EXACT, S.A.

EUDAMED last updated this device on Mar 13, 2025

S16X10

8445594_TORN_ORTO_QQ

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EM EXACT, S.A.
UDI-DI code: 08445594017331
Reference / catalog number: S16X10

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Manufacturer information

Organization name: EM EXACT, S.A.
SRN: ES-MF-000010830
Manufacturer status: Active

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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

1 warning recorded — scroll inside the panel to see all entries.

CW999
Operations should not be performed on patients with immune deficiencies, on steroid treatment, patients with blood coagulation problems, endocrine diseases, rheumatic diseases, low bone density, liver cirrhosis or other similar diseases. Micros-crew surgeries should not be performed in patients suffering from osteomyelitis, who have received radiotherapy to the skull, who suffer from gingival diseases or who have oral hygiene problems. This product should not be used on patients who are sensitive to the raw material titanium. Not for use in cases of active or suspected infection or in patients previously sensitised to titanium. It should not be used in patients who have conditions that would cause the patient to ignore the limitations of the rigid fixation micro-screws.

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: 08445594017331
Basic UDI-DI: 8445594_TORN_ORTO_QQ
Reference / catalog number: S16X10
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
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)

Q010499ORTHODONTIC DEVICES - 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
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Software identification