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

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

MD Atlas
EM EXACT, S.A.

EUDAMED last updated this device on May 17, 2024

BLACKCAP

8445594_ACC_PIL_SOBRE_P9

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: EM EXACT, S.A.
UDI-DI code: 08445594006779
Reference / catalog number: BLACKCAP

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

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		Still on market
Italy		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08445594006779
Basic UDI-DI: 8445594_ACC_PIL_SOBRE_P9
Reference / catalog number: BLACKCAP
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

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.