WHITE LABEL MANUFACTURER · MEDICAL DEVICES

Manufacturer of sterile compresses steam-sterilized white-label - Without OE · LPP · ISO 13485

Reimbursed under the French LPP list at a dedicated nominal rate. Free of ethylene oxide residue. For pharmacies, pharmacy groups, and laboratories.

ISO 13485

MDR 2017/745

CE Marking

Reimbursed by LPP

OE Residue-Free

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white-label steam-sterilized sterile gauze pads

Since October 31, 2025, steam-sterilized compresses have been granted a higher specific LPP reimbursement rate than generic ethylene oxide (EO)-sterilized compresses—whose prices are dropping by 14.4% in two waves between now and November 2026. Smart Agents Healthcare offers pharmacists, pharmacy groups, and laboratories the manufacturing of steam-sterilized private label (PL) sterile compresses that comply with LPP specifications and are ISO 13485 certified. A better reimbursement rate. A strong CSR argument. A tangible differentiator in the pharmacy. Under your own brand.

white-label steam-sterilized sterile gauze pads
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Product Data Sheet :

  • Reference  COMP-VAP-01
  • Types  Sterile non-woven swabs / Sterile hydrophilic gauze swabs
  • Sterilization process Saturated steam — EN ISO 17665
  • Available formats 7.5 × 7.5 cm · 10 × 10 cm
  • Packaging Box of 10 bags × 2 / 25 bags × 2 / 50 bags × 2
  • Subject : Nonwoven fabric (polyester/viscose) or 100% hydrophilic cotton gauze
  • Certifications ISO 13485 · MDR 2017/745 · CE Marking
  • LPP Reimbursement Title I, Chapter 3, Section 1, Subsection 3, (Headings B and C)
  • Residue-free No ethylene oxide residue
  • Usage Wound cleaning · Dressing application · Neonatology · OE allergic patients
  • Minimum Order Quantity On quote according to format and packaging
  • Time-to-market 4 to 6 months (first order)
  • Renewal 6 to 10 weeks
  • Packaging Fully customized to your brand (logo, guidelines, mandatory mentions)
  • Delivery France · Europe · Export

They trust us
Our partners
Laboratories, pharmaceutical groups, and distributors who trust us.

  • Pharmaceutical Partner
  • Pharmaceutical factory partner
  • Pharmaceutical factory partner
  • Pharmaceutical factory partner

Today we are supporting several major players in the pharmaceutical sector, such as’Evolupharm, Pharma Best or else Juvasanté, in the development and manufacturing of their private label physiological serums.

A leading industrial player

Means of production worthy of your ambitions

References
manufactured and shipped

Months on average 
time to market

Partners who
trust us

Units produced per year

FAQ - What Pharmacists and B2B Buyers Ask Us

Since October 31, 2025, steam-sterilized compresses can benefit from a dedicated named LPP line (under brand name), whereas EO compresses are listed under a generic description with prices dropping by an average of 14,4% by November 2026. The main advantage is having an identifiable reimbursable line for your brand, with a stable price until September 2027. Beyond reimbursement, steam sterilization addresses a genuine CSR challenge: it eliminates the use of ethylene oxide, a gas classified as CMR (carcinogenic, mutagenic, toxic for reproduction), both for patients and production operators. Offering an EO-residue-free range means aligning your offer with the growing environmental and health expectations of patients, prescribers, and health authorities.

Yes. The absence of ethylene oxide residues makes them particularly suitable for fragile patients (neonatology, pediatrics) and patients with an allergy or sensitivity to EtO — an argument expressly adopted by the HAS in its CNEDiMTS opinion of June 2025.

Our compresses are produced in ISO 13485-certified partner factories in Asia. The «steam sterilization / EO residue-free» feature is fully preserved and constitutes the main differentiating advantage. For a project with a specific requirement for French production, contact us to discuss available options.

Our partner factory has CE scope covering steam sterilization according to EN ISO 17665 standard. The certificate and process validation documents are provided upon request prior to any order.

Yes, that is possible. The previous HARTMANN product (MEDICOMP/STERILUX, registered in October 2025) constitutes a proven standard file: EO toxicology, Article R4412-66, ISO 10993-7, materiovigilance. We supply steam compresses compliant with the LPP specifications and we assist you in compiling the registration file, in conjunction with a specialized regulatory consultant. Final obtaining of the code remains subject to evaluation by the HAS and the CEPS.

4 to 6 months for a first launch. For renewals on an existing reference: 6 to 10 weeks.