← Back to catalogue
Silicone Vac Drain Bag System, Round
EUDAMEDClass IIa (EU MDR)
Ref PR0940-940580
Identity
- Trade Name
- Silicone Vac Drain Bag System, Round EUDAMED
- Device Name
- Silicone Vac Drain Bag System, Round EUDAMED
- Model / Reference
- PR0940-940580 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182605193 EUDAMED
- Basic UDI-DI
- B-04711182605193 EUDAMED
- EMDN Code
- A0601010102 DRAINAGE SYSTEMS WITH RESERVOIR EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Silicone Vac Drain Bag System, Round by Fortune Medical Instrument Corp. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04711182605193 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 80590227-3641-49a0-95d6-d1f2e1d401fe 61 fields · synced Jul 10, 2026