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

Isletest IAA ELISA — IVDD — General IVDD by BIOEUROPE GmbH

MD Atlas
BIOEUROPE GmbH

EUDAMED last updated this device on May 13, 2024

Isletest IAA ELISA

B-7011AM

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: BIOEUROPE GmbH
UDI-DI code: D-7011AM
Reference / catalog number: 7011

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: BIOEUROPE GmbH
SRN: DE-MF-000039230
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: Isletest IAA ELISA
UDI-DI code: D-7011AM
Basic UDI-DI: B-7011AM
Reference / catalog number: 7011
Issuing entity: EUDAMED

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Circulating Autoantibodies Against Human Insulin Test
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0102060104INSULIN ANTIBODY

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Bioeurope 14 Food Intolerance Test (ref:7182)B-7182BHOn the market Bioeurope 14 Food Intolerance Test (ref:7194)B-42623675671946On the market Bioeurope 4 Food Intolerance Test (ref:7184)B-7184BMOn the market Bioeurope 4 Food Intolerance Test (ref:7187)B-7187BTOn the market Bioeurope 42 Food Intolerance Test (ref:7179)B-42623675671793On 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.