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Organization name
UDI-DI code
Reference / catalog number

8654 — Class I MDR by EM EXACT, S.A.

MD Atlas
EM EXACT, S.A.

EUDAMED last updated this device on Mar 4, 2025

8654

8445594_PUNTA_INSER_YU

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EM EXACT, S.A.
UDI-DI code: 08445594026647
Reference / catalog number: 8654

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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 products is contraindicated in patients with conditions that rule out surgery to place dental implants. Reusable products manufactured by EM Exact, S.A. are subject to wear and tear as they are reused. Before each use, check the condition of the product to confirm that it is in perfect condition. If there are signs of wear and/or corrosion, discard the product, thus ending its useful life. These products should not be used on patients sensitive to their raw materials: Titanium, Stainless Steel or Peek. In the specific case of Scanbodies: - In order to achieve an accurate reading in scanning, the locators should not be marked or modified, as this could mean it would not be recognized by the software. - The scanbody should be replaced if any wear indicator is detected. - emexact® Locators are designed for use with the corresponding compatible implant system, specified in the description, and only for the specific platform (diameter). - Scanbodies should not be used with an incompatible connection.

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: 08445594026647
Basic UDI-DI: 8445594_PUNTA_INSER_YU
Reference / catalog number: 8654
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010280PROSTHETIC DENTISTRY DEVICES - 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification