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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

Medisole Heel Spur Women size 38 — Class I MDR by Dumco B.V.

MD Atlas
Dumco B.V.

EUDAMED last updated this device on Feb 13, 2026

Medisole Heel Spur Women size 38

8717286104CH

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dumco B.V.
UDI-DI code: 08717286007846
Reference / catalog number: 53104038

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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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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.

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: Medisole Heel Spur Women size 38
UDI-DI code: 08717286007846
Basic UDI-DI: 8717286104CH
Reference / catalog number: 53104038
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 designed to relieve discomfort from symptoms of heel spurs, plantar fasciitis or irritation, inflammation of the plantar fascia. The design helps to reduce stress on the plantar fascia and improve pressure distributing during walking and standing. The insole incorporates hard and soft zones, with the soft zone positioned under the plantar fascia for targeted cushioning and shock absorption. The insoles are intended for wearing inside standard footwear by adults.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: Shoe size — 36–48 MU999

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.

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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