Pe-Ha-Luron®F

Viscoelastic solution for intraocular use
based on bio-fermented sodium hyaluronate.

Pe-Ha-Luron®F is a premium ophthalmic viscoelastic developed to
provide precision, clarity, and safety across a wide range of anterior
segment procedures — from routine cataract surgery to complex intraocular cases.

1.0 – 3.0% Concentration | 1.0 ml Syringe | Steam Sterilized
42 Month Shelf Life | CE (MDR) Certified

Pe-Ha-Luron®F 3.0%
Clinical

APPLICATION

Pe-Ha-Luron®F is indicated for intraocular use in cataract surgery and other anterior segment procedures requiring chamber maintenance and tissue protection.

The product line provides surgeons with a broad concentration range, allowing selection of the optimal viscoelastic properties depending on surgical complexity and technique.

PRODUCT RANGE & CONCENTRATIONS

Pe-Ha-Luron®F is available in multiple concentrations to support different surgical requirements.

KEY FEATURES

Ultra-pure bio-fermented
sodium hyaluronate

Bio-fermented material ensuring high purity and consistent batch quality.

Steam
sterilized

Bio-fermented material ensuring high purity and consistent batch quality.

Vegan formula
(no animal-derived ingredients)

Bio-fermented material ensuring high purity and consistent batch quality.

Shelf life:
42 months

Bio-fermented material ensuring high purity and consistent batch quality.

Two layers of protection
for maximum safety

Bio-fermented material ensuring high purity and consistent batch quality.

CE certified
(MDR compliant)

Bio-fermented material ensuring high purity and consistent batch quality.

TECHNICAL SPECIFICATIONS

General Product Information
Parameter
Specification
Product Type
Ophthalmic viscoelastic device (OVD)
Active Substance
Sodium hyaluronate (bio-fermented)
Concentration Range
1.0% – 3.0%
Fill Volume
1.0 ml
Intended Use
Intraocular use in anterior segment surgery
Parameter
Specification
Molecular Weight
Approx. 1.0 – 2.2 MDa (depending on concentration)
Viscosity
Approx. 20,000 – 300,000 mPas (depending on concentration)
Viscoelastic Behavior
Cohesive (concentration-dependent performance)
Parameter
Specification
Sterilization Method
Steam sterilization
Endotoxin Level
Compliant with applicable standards
Animal-Derived Components
None (vegan formula)
Shelf Life
42 months
Parameter
Specification
Syringe Type
Pre-filled sterile syringe
Cannula
27G or 23G (depending on concentration)
Storage Conditions
2°C – 25°C
Single Use
Yes

REGULATORY & QUALITY

Pe-Ha-Luron®F is manufactured in compliance with applicable international medical device regulations and quality management standards. The product is CE certified under the European Medical Device Regulation (MDR) and produced within a certified quality management system to ensure consistent safety, performance, and traceability.

All manufacturing processes are conducted under controlled conditions to guarantee product integrity, sterility, and batch consistency.

Regulatory Compliance

  • CE marked medical device
  • Compliant with European Medical Device Regulation (MDR)
  • Product documentation available upon request

Quality Management

  • Manufactured under certified Quality Management System
  • Controlled production and batch testing
  • Full product traceability

Safety & Material Standards

  • Bio-fermented sodium hyaluronate
  • No animal-derived ingredients
  • Sterility validated according to applicable standards

DOCUMENTATION &
REGULATORY INFORMATION

Comprehensive regulatory and technical documentation for Pe-Ha-Luron®F is available to qualified partners and distributors. To ensure compliance with international medical device regulations and proper documentation handling, access is provided via our secure partner portal.

Available Documentation

  • Instruction for Use (IFU)
  • CE Certificate
  • Declaration of Conformity
  • Technical Data Sheet
  • Product Brochure
  • Further Marketing Materials

BECOME A
DISTRIBUTION PARTNER

ALBOMED collaborates with qualified distribution partners worldwide to ensure reliable market access and professional product representation.

We support our partners with regulatory documentation, marketing materials, and technical expertise to facilitate successful market development.

Why Partner with ALBOMED

  • German medical device manufacturer
  • Certified quality management system
  • Reliable production and supply chain
  • Regulatory and technical support
  • Long-term partnership approach

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