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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

CellTram® 4m Air — Class I MDR by BIOZOL Diagnostica…

MD Atlas
BIOZOL Diagnostica Vertrieb GmbH

EUDAMED last updated this device on Jun 27, 2025

CellTram® 4m Air

426245279CellTram4mAir4Y

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: BIOZOL Diagnostica Vertrieb GmbH
UDI-DI code: 04262452790014
Reference / catalog number: EPE-5196000021

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Manufacturer information

Organization name: BIOZOL Diagnostica Vertrieb GmbH
SRN: DE-MF-000043808
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.

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: CellTram® 4m Air
UDI-DI code: 04262452790014
Basic UDI-DI: 426245279CellTram4mAir4Y
Reference / catalog number: EPE-5196000021
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: The CellTram® 4m Air has been designed and manufactured to support the injection and aspiration of cells or cell components during the performance of assisted reproductive technologies (ART) such as intracytoplasmic sperm injection (ICSI), or the collection of genetic material for the purpose of genetic preimplantation testing (PGT), using micro tools (e.g., microcapillaries or micro glass pipettes). CellTram® 4m Air is a pneumatic microinjector
Additional information URL: https://cmi.calibrescientific.com/en
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U08020399DEVICES FOR MICROMANIPULATION OF BIOLOGICAL MATERIAL FOR ASSISTED REPRODUCTION - OTHER

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

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