Our products & their certification

Piumella is the shop

Piumella is the retail brand under which MARV, s.r.o. (Medkova 1591/34, 500 02 Hradec Králové, Czech Republic) curates and sells medical compression legwear across the European Union. We are a distributor of medical devices — not their manufacturer. Names like “Knee-High · Class 1” describe our edit of the range, in our sizes and colours.

The products are XZ

The stockings, pantyhose and leggings we sell are XZ medical compression garments. XZ is the brand you will find on the product and its sealed box; Piumella is the boutique that curates and sells them.

Manufacturer declaration

The declaration of conformity we hold is issued by Hunan Xiangzi Medical Devices Technology Co., Ltd., 2nd Floor, Bldg 1, Phase 1, Electronic Industrial Park, Longling Industrial Concentration Area, Yiyang, Hunan, 413046, China. Manufacturer SRN: CN-MF-000038157.

Document D-YQ-MD-230808106/02, dated 8 August 2023, identifies the product as “Medical varicose compression stockings” and declares the listed models to be class I medical devices, rule 1, under Regulation (EU) 2017/745. The declaration is issued under the sole responsibility of the manufacturer and states that the devices bear the CE mark.

European authorised representative

The representative named in that declaration is Humiss Beratung GmbH, Gneisenaustraße 8, 40477 Düsseldorf, Germany. SRN: DE-AR-000023447. Contact: eurep@humiss.com.

EUDAMED records

The manufacturer is listed in the European Commission’s EUDAMED register under SRN CN-MF-000038157. Its Medical varicose compression stockings family is recorded under Basic UDI-DI 697355124900KH. Basic UDI-DI identifies a device family; the UDI on an individual product label identifies the specific device. Registration is not a separate quality certificate.

Manufacturer’s product manual

The Medical varicose compression stockings product manual, revised 28 June 2024, specifies 15–21 mmHg for compression class I and 23–32 mmHg for compression class II, measured at the ankle. It lists 70% nylon and 30% spandex and explains the manufacturer’s model codes by compression level, garment length and size.

Follow the manufacturer’s instructions and seek professional advice before first use and when selecting compression or size. The manual contains contraindications and handling instructions; a product’s medical-device classification does not mean it is suitable for every wearer.

Medical-device class and compression class

Medical-device class I is the regulatory classification. Compression classes I and II describe pressure ranges and are a different classification. A manufacturer’s CE declaration is not an independent RAL compression certificate. Follow the specific product’s label and instructions for its compression, sizing and intended use.

Documents on request

For the manufacturer’s declaration and the instructions applicable to a specific product, contact info@piumella.com or call +420 774 652 762.