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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

HP-15 — Class IIb MDR by VH Pharma a.s.

MD Atlas
VH Pharma a.s.

EUDAMED last updated this device on May 12, 2026

HP-15

859417749HEMAGELPROCTOTN

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VH Pharma a.s.
UDI-DI code: 08594177490334
Reference / catalog number: HP-15

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Manufacturer information

Organization name: VH Pharma a.s.
SRN: CZ-MF-000005951
Manufacturer status: Active

Critical warnings

4 warnings recorded — scroll inside the panel to see all entries.

CW999
In case of adverse effects, discontinue use and consult a physician.
CW032
EUDAMED did not publish a description for this code.
CW135
EUDAMED did not publish a description for this code.
CW999
For rectal use only. Do not swallow or apply to other body orifices.

Market distribution

Primary placement in Czechia; available across 1 country total.

Country	On market since	Until
CzechiaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594177490334
Basic UDI-DI: 859417749HEMAGELPROCTOTN
Reference / catalog number: HP-15
Issuing entity: GS1

Classification

Risk category: Class IIb
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Rectal suppositories, pack of 15 units
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

M040499DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER

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

HN-100859417749HEMAGELNEWPFOn the market HN-30859417749HEMAGELNEWPFOn the market HN-5859417749HEMAGELNEWPFOn the market HP-10859417749HEMAGELPROCTOTNOn the market HP-5859417749HEMAGELPROCTOTNOn the market

Certificates

Certificate health across this manufacturer's portfolio.

25 0399 QR/NBIssued
Quality management systemNotified body: 1023Expiry: Oct 30, 2030
25 0237 QR/NBIssued
Quality management systemNotified body: 1023Expiry: Jun 25, 2030