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Organization name
UDI-DI code
Reference / catalog number

Normal Saline for irrigation… — Class IIa MDD

MD Atlas
Laboratorios Grifols S.A.

EUDAMED last updated this device on Apr 29, 2026

Normal Saline for irrigation Grifols

B-ESMF000000767725061UN

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Laboratorios Grifols S.A.
UDI-DI code: D-ESMF000000767725061UN
Reference / catalog number: 725061

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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
- The solutions for irrigation Grifols must not be injected. - The preparation should be used only once. Any solution fraction should be discarded. - It contains phthalate, hence precaution should be maximised in at risk populations. - There is limited evidence on the relationship between exposure to DEHP and its adverse effects on humans, although it may eventually produce effects on the development and the reproductive system. - The product reuse poses risk of infection.

Market distribution

Primary placement in Spain; available across 2 countries total.

Country	On market since	Until
SpainPrimary placement	May 19, 1999	Still on market
Portugal	Dec 21, 2012	Still on market

Device identification

Trade name: Normal Saline for irrigation Grifols
UDI-DI code: D-ESMF000000767725061UN
Basic UDI-DI: B-ESMF000000767725061UN
Reference / catalog number: 725061
Issuing entity: EUDAMED

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The product NORMAL SALINE FOR IRRIGATION GRIFOLS is an isotonic, sterile and non-pyrogenic 0.9% sodium chloride solution, indicated in the endoscopic transurethral procedures that require the distension and irrigation of the urinary bladder. It consists of a poly(vinyl chloride) (PVC) bag of 3000 ml closed with a polycarbonate connector with a butyl rubber stopper.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

U0380DEVICES FOR URINARY TRACT DILATION - ACCESSORIES

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

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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.