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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

EAR ROD COVER DISPOSABLE CC3 — Class I MDR by PaloDEx Group Oy

MD Atlas
PaloDEx Group Oy

EUDAMED last updated this device on Aug 11, 2025

EAR ROD COVER DISPOSABLE CC3

643003587HygieneSheath4N

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: PaloDEx Group Oy
UDI-DI code: 06430035873500
Reference / catalog number: 6801150-SDX

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Manufacturer information

Organization name: PaloDEx Group Oy
SRN: FI-MF-000004943
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
EUDAMED did not publish a description for this code.

Market distribution

Primary placement in Finland; available across 1 country total.

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

Device identification

Trade name: EAR ROD COVER DISPOSABLE CC3
UDI-DI code: 06430035873500
Basic UDI-DI: 643003587HygieneSheath4N
Reference / catalog number: 6801150-SDX
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: —
Additional information URL: https://www.elabeling.dexis.com/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z11030585RADIOLOGY INSTRUMENTS - CONSUMABLES

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

ORTHOPANTOMOGRAPH™ OP 3D643003587OP3D9AOn the market ORTHOPANTOMOGRAPH™ OP 3D EX643003587OP3D9AOn the market Bite block 10 pcs643003587PatPosXLOn the market Bite Block Disposable Cover643003587HygieneSheath4NOn the market Carpus Holder643003587PatPosXLOn the market

Certificates

Certificate health across this manufacturer's portfolio.

CR-03-1154-812-23Supplemented
Quality management systemNotified body: 0537Expiry: Mar 6, 2028