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Organization name
UDI-DI code
Reference / catalog number

STARFIT® ENFIT MALE CAP MC01 — Class I MDR by HOIST MEDICAL

MD Atlas
HOIST MEDICAL

EUDAMED last updated this device on Mar 19, 2025

STARFIT® ENFIT MALE CAP MC01

376034811400.07CE

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: HOIST MEDICAL
UDI-DI code: 03760348110126
Reference / catalog number: MC01

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Manufacturer information

Organization name: HOIST MEDICAL
SRN: FR-MF-000026140
Manufacturer status: Active

Critical warnings

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

CW009
EUDAMED did not publish a description for this code.
CW007
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in France; available across 1 country total.

Country	On market since	Until
FrancePrimary placement	Feb 28, 2025	Still on market

Device identification

Trade name: STARFIT® ENFIT MALE CAP MC01
UDI-DI code: 03760348110126
Basic UDI-DI: 376034811400.07CE
Reference / catalog number: MC01
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: ENFit® male cap for enteral device securing
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

G0280GASTROINTESTINAL TUBES - 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

Certificates

Certificate health across this manufacturer's portfolio.

1000217799Issued
Quality management systemNotified body: 0297Expiry: Oct 31, 2029

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