← Back to catalogue
Glolen
EUDAMEDClass IIa (EU MDR)
Ref 3630011GModel Blood line Set for haemodialysis (Pre-Pump and Post-Pump)Ref 3630022G
Identity
- Trade Name
- Glolen EUDAMED
- Device Name
- Blood line Set for haemodialysis EUDAMED
- Model / Reference
- Blood line Set for haemodialysis (Pre-Pump and Post-Pump) EUDAMED3630011G EUDAMED3630022G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08903545081539 EUDAMED08903545081546 EUDAMED
- Basic UDI-DI
- 8903545GMLBLH005ED EUDAMED
- EMDN Code
- F020180 ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION -HAEMODIAFILTRATION - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Glolen by Global Medikit Limited — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 8903545GMLBLH005ED | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Global Medikit Limited
- EUDAMED SRN
- IN-MF-000013635
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 5b054261-e485-463a-b472-5277aeea8d44 61 fields · synced Jul 23, 2026
- EUDAMED 66c45e6e-3016-4bd9-80f0-bdcc184c2a66 61 fields · synced May 19, 2026