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Organization name
UDI-DI code
Reference / catalog number

gΛt RePrint® collection device — Class I MDR by MaaT Pharma

MD Atlas
MaaT Pharma

EUDAMED last updated this device on Oct 2, 2024

gΛt RePrint® collection device

3770013007005S

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: MaaT Pharma
UDI-DI code: 03770013007002
Reference / catalog number: 6D003

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Manufacturer information

Organization name: MaaT Pharma
SRN: FR-MF-000004549
Manufacturer status: Active

Critical warnings

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

CW999
Collect only faeces, no urine, no blood, and no waste.
CW032
EUDAMED did not publish a description for this code.
CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.
CW020
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Placed on the market in France; per-country availability dates not published.

Device identification

Trade name: gΛt RePrint® collection device
UDI-DI code: 03770013007002
Basic UDI-DI: 3770013007005S
Reference / catalog number: 6D003
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: collection of faeces for microbiotherapy fecal suspensions manufacturing.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

A99DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - 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

Related devices

gΛt RePrint®3770013007015UOn the market gΛt RePrint® administration tubing3770013007025WOn 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.