16454

Organization name

Vitrolife A/S

SRN

DK-MF-000001892

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

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

• CW007

  Symbol: ISO 15223-1:2021 (5.2.8)
• CW009

  Symbol: ISO 15223-1:2021 (5.4.2)
• CW010

  Symbol: ISO 15223- 1:2021 (5.4.3)
• CW011

  Federal law restricts this device to sale by or on the order of a physician or a practitioner trained in its use.

Primary placement in Denmark; available across 32 countries total.

Trade name

not provided

UDI-DI code

05712714664540

Basic UDI-DI

5712714DISH-01M2

Reference / catalog number

16454

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://www.vitrolife.com/support/support-material/support-documents?type=productmanual

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• U080206CULTURE PLATES FOR ASSISTED REPRODUCTION