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Organization name
UDI-DI code
Reference / catalog number

735202 — Class I MDR by Laboratorios Grifols S.A.

MD Atlas
Laboratorios Grifols S.A.

EUDAMED last updated this device on Nov 26, 2025

735202

8437017294A070001N7

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Laboratorios Grifols S.A.
UDI-DI code: 08437017294047
Reference / catalog number: 735202

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Manufacturer information

Organization name: Laboratorios Grifols S.A.
SRN: ES-MF-000000767
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW999
- Do not use if the individual package is not intact or if the protective caps are damaged or missing. - Do not use if the packaging is damaged or presents visible signs of damage. - The sterile barrier system is the individual package. - Once the individual package is opened, the product must be used immediately. - Use immediately after removing the protective caps. - Do not use the product if the expiry date has been exceeded (see expiry date indicated in the individual package). - Single use product. Do not re-use. The product reuse poses risk of infection. To avoid cross contamination, change the set when source solutions are changed. Replace the set at least every 24 hours. - Do NOT connect the product directly to the patient. - Check the compatibility with drugs before use. - Pay attention to the warning messages displayed on the screen of the Gri-fill Pharmacy Compounder.

Market distribution

Primary placement in EL; available across 1 country total.

Country	On market since	Until
ELPrimary placement	Aug 28, 2025	Still on market

Device identification

Trade name: not provided
UDI-DI code: 08437017294047
Basic UDI-DI: 8437017294A070001N7
Reference / catalog number: 735202
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: Gri-fill 2 Ways Set is a single-use, sterile, non-pyrogenic fluid transfer set for use with the Gri-fill pharmacy compounder in order to compound or mix different multi-ingredient solutions and to channel them into a final container. The set is a disposable component of the compounder. The principal components of the Gri-fill 2 Ways Set are a syringe, a distributor, tubing to channel the fluid and a waste/residue bag. Also a Luer female - female adapter and a mini-spike are available as auxiliary components to the Gri-fill 2 Ways Set. It is supplied sterile in individual sealed peel-pack pouches.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A0704SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS

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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

1.5% Glycine GrifolsB-ESMF000000767725176V8On the market 725060B-ESMF000000767725060ULOn the market Bags for Gri-fill System: Gri-Bag8437017294A080001NJOn the market Bags for Gri-fill System: Gri-Bag8437017294A080001NJOn the market Bags for Gri-fill System: Gri-Bag8437017294A080001NJOn 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.