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Organization name
UDI-DI code
Reference / catalog number

8116 — Class IIb MDR by EM EXACT, S.A.

MD Atlas
EM EXACT, S.A.

EUDAMED last updated this device on May 15, 2024

8116

8445594_TORN_RECT_LQ

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EM EXACT, S.A.
UDI-DI code: 08445594019502
Reference / catalog number: 8116

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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
The use of the products is contraindicated in the case of patients with conditions that rule out the use of surgery for the placement of dental implants. The use of the products is contraindicated in the case of patients in whom the desired sizes, numbers or positions of the implants cannot be achieved to achieve a safe support of functional or possibly parafunctional loads. These products should not be used on patients sensitive to their raw materials: Titanium, Chrome-Cobalt or Peek.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	Jul 1, 2024	Still on market
Italy	Jul 1, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08445594019502
Basic UDI-DI: 8445594_TORN_RECT_LQ
Reference / catalog number: 8116
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)

P01020180DENTAL IMPLANTS - ACCESSORIES

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

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Expiration date
Manufacturing date
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Software identification