Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

HN-5 — Class IIb MDR by VH Pharma a.s.

MD Atlas
VH Pharma a.s.

EUDAMED last updated this device on May 12, 2026

HN-5

859417749HEMAGELNEWPF

On the marketClass IIb

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: VH Pharma a.s.
UDI-DI code: 08594177490815
Reference / catalog number: HN-5

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

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

Related devices

HN-100859417749HEMAGELNEWPFOn the market HN-30859417749HEMAGELNEWPFOn the market HP-10859417749HEMAGELPROCTOTNOn the market HP-15859417749HEMAGELPROCTOTNOn the market HP-5859417749HEMAGELPROCTOTNOn the market

Critical warnings

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

CW999
Discontinue the treatment in case of incidence of adverse effects (increased pain, redness, allergic reaction) and contact your attending physician.
CW135
EUDAMED did not publish a description for this code.
CW032
EUDAMED did not publish a description for this code.
CW999
For external use only. Do not use internally.

Market distribution

Primary placement in Czechia; available across 3 countries total.

Country	On market since	Until
CzechiaPrimary placement		Still on market
Spain		Still on market
Slovakia		Still on market

Device identification

Trade name: not provided
UDI-DI code: 08594177490815
Basic UDI-DI: 859417749HEMAGELNEWPF
Reference / catalog number: HN-5
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: Hydrophilic gel with IPN polymer, tube of 5 grams
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: 5 MU24

EMDN nomenclature code(s)

M04040501HYDROGEL DRESSINGS, NON-COMBINED

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

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