Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

LAN-BIRA1612T — Class IIb MDR by EM EXACT, S.A.

MD Atlas
EM EXACT, S.A.

EUDAMED last updated this device on Mar 11, 2025

LAN-BIRA1612T

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: 08445594021246
Reference / catalog number: LAN-BIRA1612T

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

123718445594_PILAR_CEM_MONO_WKOn the market 55728445594_PILAR_SOBRE_BL_4BOn the market 55468445594_PILAR_SOBRE_BL_4BOn the market 107758445594_PILAR_CEM_MONO_WKOn the market 107628445594_PILAR_CEM_MONO_WKOn 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

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: 08445594021246
Basic UDI-DI: 8445594_TORN_ORTO_QQ
Reference / catalog number: LAN-BIRA1612T
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
Serial number
Software identification