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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

Solhemo — Class IIb MDR by Sterima

MD Atlas
Sterima

EUDAMED last updated this device on May 26, 2026

Solhemo

5412977AconcentratePK

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Sterima
UDI-DI code: 05412977000986
Reference / catalog number: 30425000095

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View device family (Basic UDI)

Manufacturer information

Organization name: Sterima
SRN: BE-MF-000017855
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW011
Acid concentrate to be used in extracorporeal bicarbonate-based haemodialysis, haemodiafiltration or haemofiltration, for patients suffering from acute or chronic renal failure. Acid concentrate intended to be used as one component in the preparation of dialysate in a three-stream proportioning haemodialysis machine. Check conductivity and where applicable pH of the final dialysate prior to dialysis treatment, in line with the haemodialysis machine manufacturer’s instructions. Dilute acid concentrate with water meeting the requirements of ISO 23500-3. Sodium bicarbonate is to be added before use. Do not over mix with bicarbonate concentrate. Dilute acid concentrate immediately before use. Refer to the haemodialysis machine manufacturer’s instructions for mixing of dialysate. Consider all sources of buffer including the bicarbonate concentrate and the acetate and/or citrate in the acid concentrate. Do not use for intravenous infusion. Dispose unused concentrate in accordance with local regulations.
CW007
EUDAMED did not publish a description for this code.

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Market distribution

Primary placement in Belgium; available across 2 countries total.

Country	On market since	Until
BelgiumPrimary placement		Still on market
France		Still on market

Device identification

Trade name: Solhemo
UDI-DI code: 05412977000986
Basic UDI-DI: 5412977AconcentratePK
Reference / catalog number: 30425000095
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Acid concentrate to be used in extracorporeal bicarbonate-based haemodialysis, haemodiafiltration or haemofiltration, for patients suffering from acute or chronic renal failure. Acid concentrate intended to be used as one component in the preparation of dialysate in a three-stream proportioning haemodialysis machine. Check conductivity and where applicable pH of the final dialysate prior to dialysis treatment, in line with the haemodialysis machine manufacturer’s instructions. Dilute acid concentrate with water meeting the requirements of ISO 23500-3. Sodium bicarbonate is to be added before use. Do not over mix with bicarbonate concentrate. Dilute acid concentrate immediately before use. Refer to the haemodialysis machine manufacturer’s instructions for mixing of dialysate. Consider all sources of buffer including the bicarbonate concentrate and the acetate and/or citrate in the acid concentrate. Do not use for intravenous infusion. Dispose unused concentrate in accordance with local regulations.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)05412977000986

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

F040101DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE

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

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Certificates

Certificate health across this manufacturer's portfolio.

B26/00000039Issued
Quality management systemNotified body: 1639Expiry: Feb 16, 2031

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