Identity
- Trade Name
- PM-O-LINE EUDAMED
- Device Name
- Extension Line EUDAMED
- Model / Reference
- GS-3036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08902120303691 EUDAMED08902120303653 EUDAMED08902120303660 EUDAMED08902120303677 EUDAMED08902120303639 EUDAMED08902120303622 EUDAMED08902120303615 EUDAMED08902120303608 EUDAMED
- Basic UDI-DI
- 8902120C011RR EUDAMED
- EMDN Code
- A03020102 HIGH PRESSURE EXTENSION LINES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
Pm-O-Line by Romsons International (Unit II) — 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 | 8902120C011RR | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Romsons International (Unit II)
- EUDAMED SRN
- IN-MF-000024594
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (8)
- EUDAMED bccdee3c-7ac2-4487-8f98-75d8257beb86 61 fields · synced Aug 2, 2026
- EUDAMED df78a44e-e224-4659-b3cb-c1d59b2c4d84 61 fields · synced May 11, 2026
- EUDAMED aabd062a-d119-4092-a200-6665418f924d 61 fields · synced May 17, 2026
- EUDAMED 7e831200-54b4-4e4d-a246-075968bbfa2a 61 fields · synced May 17, 2026
- EUDAMED 47c12edc-7382-459e-800a-ce1465a6f786 61 fields · synced May 18, 2026
- EUDAMED 12867926-d47d-4b8f-ac40-0ed9823ee3b9 61 fields · synced May 18, 2026
- EUDAMED dffc8e37-d592-466a-b1c0-58a425e9a29f 61 fields · synced May 18, 2026
- EUDAMED 7bb08686-eca0-45ec-9e4a-26ca22c27ec2 61 fields · synced May 19, 2026