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

NSE (QR105) — IVDD — General IVDD by biocyc Biotechnologie…

MD Atlas
biocyc Biotechnologie GmbH & Co. KG

EUDAMED last updated this device on Oct 24, 2023

NSE (QR105)

B-C-N005-025PK

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: biocyc Biotechnologie GmbH & Co. KG
UDI-DI code: D-C-N005-025PK
Reference / catalog number: C-N005-025

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: biocyc Biotechnologie GmbH & Co. KG
SRN: DE-MF-000031533
Manufacturer status: Active

Related devices

005 PolyQ Stain DAB Substrate Buffer42555978DETECCHR103P6On the market Albumin FITCB-C-FA005-20SKOn the market Albumin FITCB-P-FA005-706WOn the market Albumin FITCB-P-FA005-306JOn the market Albumin FITCB-C-FA005-10SGOn the market

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: NSE (QR105)
UDI-DI code: D-C-N005-025PK
Basic UDI-DI: B-C-N005-025PK
Reference / catalog number: C-N005-025
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: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W01030709PRIMARY ANTISERA FOR IMMUNOHISTOLOGY

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

Certificates

Certificate health across this manufacturer's portfolio.

HX 1108389-1Issued
refdata.certificate-ivdr-type.quality-management-systemNotified body: 0197Expiry: Jun 20, 2029