Biotech Europe Meditech Inc Ltd
Active in EUDAMEDIrelandfrom SRN EUDAMED FDA SRN IE-MF-000004695 FEI 3016942176
- Devices
- 6
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
Catalogue
- Regimes: CE MDR Registry: EUDAMED
- Regimes: CE MDR Registry: EUDAMED
Hydroxypropyl Methyl Cellulose Ophthalmic Solutions Ref OPTIFLEX HPMC 2 ml PFS
Regimes: CE MDR Registry: EUDAMED- Regimes: CE MDR Registry: EUDAMED
- Regimes: CE MDR Registry: EUDAMED
Intraocular Lens Delivery System Ref MKT
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- IE-MF-000004695
- FDA FEI number
- 3016942176
- EU VAT number
- IE3228302QH
- EUDAMED status
- Active
- EUDAMED registered name
- Biotech Europe Meditech Inc Limited
- Registered address
- AF2, IDA Business & Technology Park, Roscommon, Ireland, F42 P862, Roscommon, Ireland
- Website
- www.biotechhealthcare.com
- [email protected]
- Phone
- +353 (0)90 666 5990
- PRRC contact
- Ranjita Gawde
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 13 May 2027
DNV Product Assurance AS 2460 1 certificate
- C537156 Expiring
Quality management system EU MDR
- Issued
- 13 May 2022
- Expires
- 13 May 2027
Frequently asked questions
How many devices does BIOTECH EUROPE MEDITECH INC LTD have in the registry?
The registry currently lists 6 devices for BIOTECH EUROPE MEDITECH INC LTD. Devices recorded under merged duplicate company entries are counted once.
Which registries list BIOTECH EUROPE MEDITECH INC LTD's devices?
Among its 6 most recently registered devices, BIOTECH EUROPE MEDITECH INC LTD has devices listed in EUDAMED (6 devices).
What risk classes do BIOTECH EUROPE MEDITECH INC LTD's devices fall under?
Among its 6 most recently registered devices, the classes recorded for BIOTECH EUROPE MEDITECH INC LTD's devices are Class IIa and Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for BIOTECH EUROPE MEDITECH INC LTD?
EUDAMED lists 1 certificate for BIOTECH EUROPE MEDITECH INC LTD (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 13 May 2022.
What are the newest devices from BIOTECH EUROPE MEDITECH INC LTD in the registry?
The most recently registered devices listed for BIOTECH EUROPE MEDITECH INC LTD include Sodium Hyaluronate Ophthalmic Solutions, Hydroxypropyl Methyl Cellulose Ophthalmic Solutions, Trypan Blue Ophthalmic Solutions and Intraocular Lens Delivery System.