BIOTECH EUROPE MEDITECH INC LTD

Ireland IE-MF-000004695 Last updated 22 Oct 2026

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Devices: 4
Registries: EUDAMEDFDA
FDA recalls: 0

Catalogue4

Hydroxypropyl Methyl Cellulose Ophthalmic Solutions Ref OPTIFLEX HPMC 2 ml PFS

Class IIb EUDAMED Active
Sodium Hyaluronate Ophthalmic Solutions Ref Optiflex HA 14mg/ml, 1ml PFS

Class IIb EUDAMED Active
Trypan Blue Ophthalmic Solutions Ref Opti Blue, 1 ml PFS

Class IIb EUDAMED Active
Intraocular Lens Delivery System Ref MKT

Class IIa EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

DNV Product Assurance AS 2460 1 certificate

C537156 Issued

Quality management system EU MDR

Issued
13 May 2022

Expires
13 May 2027

Notified bodies

DNV Product Assurance AS 2460

Information

Country: Ireland
Address: AF2, IDA Business & Technology Park, Roscommon, Ireland, Roscommon, Ireland
Website: www.biotechhealthcare.com
Email: [email protected]
Phone: +353 (0)90 666 5990
PRRC contact: Ranjita Gawde
EUDAMED SRN: IE-MF-000004695
FDA FEI number: 3016942176