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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

IM 65 — Class I MDD by INORIS MEDICAL SP. Z O.O.

MD Atlas
INORIS MEDICAL SP. Z O.O.

EUDAMED last updated this device on Oct 7, 2022

IM 65

B-05902596226398

On the marketClass I

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: INORIS MEDICAL SP. Z O.O.
UDI-DI code: 05902596226398
Reference / catalog number: IM 65

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Manufacturer information

Organization name: INORIS MEDICAL SP. Z O.O.
SRN: PL-MF-000016864
Manufacturer status: Active

Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Poland; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 05902596226398
Basic UDI-DI: B-05902596226398
Reference / catalog number: IM 65
Issuing entity: GS1

Classification

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

Device details

Quantity: 1
Additional product description: Endoscopy Biteguard with strap for adults. Its shape and used material guarantee maximum security for patient and instrument. Additionally the bite area is covered with soft flexible material which improves patient’s comfort. Biteguard has soft adjustable mounting, fastened around patient’s head which does not cause discomfort or pressure on the cheeks and face. It is designed to be used during gastroscopy, bronchoscopy and transesophageal echocardiography.
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

EMDN nomenclature code(s)

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

G030804GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS

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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Related devices

IM-20B-05902596226121On the market IM-01B-05902596226015On the market IM-02B-05902596226091On the market IM-1080B-05902596226688On the market IM-40B-05902596226244On the market

Certificates

Certificate health across this manufacturer's portfolio.

1434-MDR-007/2026Issued
Quality management systemNotified body: 1434Expiry: Apr 2, 2031