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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

53103148 — Class I MDR by Dumco B.V.

MD Atlas
Dumco B.V.

EUDAMED last updated this device on Jan 23, 2026

53103148

8717286103CF

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dumco B.V.
UDI-DI code: 08717286007815
Reference / catalog number: 53103148

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View device family (Basic UDI)

Manufacturer information

Organization name: Dumco B.V.
SRN: NL-MF-000050760
Manufacturer status: Active

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Critical warnings

No critical warnings reported for this device.

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Market distribution

Primary placement in Netherlands; available across 1 country total.

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

Device identification

Trade name: not provided
UDI-DI code: 08717286007815
Basic UDI-DI: 8717286103CF
Reference / catalog number: 53103148
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: This insole is intended for conservative treatment and symptomatic relief of Achilles tendon pain and related conditions. The insole is manufactured with uniform material hardness throughout for stability. A separately provided heel lift accessory is intended to be used in combinations with the insole to help reduce strain on the Achilles tendon during standing and walking. The insoles are intended for wearing inside standard footwear by adults.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 36–48 MU999

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08717286007815

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UDI-PI DataMatrix

The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.

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EMDN nomenclature code(s)

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

Y061203ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS)

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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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.