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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

Nuvinol — Class IIa MDD by PK Benelux BV

MD Atlas
PK Benelux BV

EUDAMED last updated this device on Apr 29, 2026

Nuvinol

B-003-NVPW

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: PK Benelux BV
UDI-DI code: D-003-NVPW
Reference / catalog number: 003-NV

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View device family (Basic UDI)

Manufacturer information

Organization name: PK Benelux BV
SRN: NL-MF-000006672
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

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

CW999
Keep out of reach of young children. If you are suffering from hypersensitivity reactions, stop using hemorrhoid gel. Do not use after the expiry date stated on the packaging. Hemorrhoid gel is not recommended in pregnant of breastfeeding woman.

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Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement	Jun 2, 2025	Still on market

Device identification

Trade name: Nuvinol
UDI-DI code: D-003-NVPW
Basic UDI-DI: B-003-NVPW
Reference / catalog number: 003-NV
Issuing entity: EUDAMED

Classification

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

Device details

Quantity: 1
Additional product description: To treat external hemorrhoids and help in relieving symptoms of hemorrhoids such as burning, itching and pain caused by swelling haemorrhoids.
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

UDI-DI DataMatrix

D-003-NVPW

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

EMDN nomenclature code(s)

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

M9002PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)

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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