Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners 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

BMKN35H — Class IIa MDR by Micerium S.p.A.

MD Atlas
Micerium S.p.A.

EUDAMED last updated this device on May 27, 2026

BMKN35H

++EMICFAM3C4A1SFZ

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Micerium S.p.A.
UDI-DI code: EMICBMKN35H1
Reference / catalog number: BMKN35H

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?

View device family (Basic UDI)

Manufacturer information

Organization name: Micerium S.p.A.
SRN: IT-MF-000010187
Manufacturer status: Active

Related devices

CHFF25++EMICFAM1DVDOn the market EM35++EMICFAM1HVMOn the market EM35V3++EMICFAM1HVMOn the market COSM05S-1++EMICFAM1FVHOn the market CHRFUD3,5++EMICestikaBBOn 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

4 warnings recorded — scroll inside the panel to see all entries.

CW007
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW010
EUDAMED did not publish a description for this code.
CW999
Contiene Nichel e Cromo può causare reazioni a pazienti allergici

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Italy; available across 1 country total.

Country	On market since	Until
ItalyPrimary placement	Dec 5, 2024	Still on market

Device identification

Trade name: not provided
UDI-DI code: EMICBMKN35H1
Basic UDI-DI: ++EMICFAM3C4A1SFZ
Reference / catalog number: BMKN35H
Issuing entity: HIBCC

Classification

Risk category: Class IIa
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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

Q010403ORTHODONTIC BRACKETS AND BUTTONS

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

Become a partner of MD Atlas