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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

RoweTrans Collection Bag 1000 ml — Class IIa MDR

MD Atlas
RoweMed AG - Medical 4 Life

EUDAMED last updated this device on May 6, 2025

RoweTrans Collection Bag 1000 ml

42503476TRANSLN

On the marketClass IIa

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: RoweMed AG - Medical 4 Life
UDI-DI code: 04250347604942
Reference / catalog number: A-3001

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Manufacturer information

Organization name: RoweMed AG - Medical 4 Life
SRN: DE-MF-000005350
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.

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW001
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW999
Exclusion of liability: if reprocessed for reuse, the physical, chemical and/or biological product properties may be changed.
CW999
This product does not replace the required hygienic and aseptic working practices. Care must be taken to avoid contamination.
CW999
If the product is damaged or dropped, do not use it.
CW999
The manufacturer's instructions for use of the blood collection bag must also be complied with.

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: RoweTrans Collection Bag 1000 ml
UDI-DI code: 04250347604942
Basic UDI-DI: 42503476TRANSLN
Reference / catalog number: A-3001
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: —
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

B010199BLOOD COLLECTION BAGS AND KITS - 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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification