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Fortune Silicone Gastroplasty Calibration Tube
EUDAMEDClass IIa (EU MDR)
Ref 2170-3039
Identity
- Trade Name
- Fortune Silicone Gastroplasty Calibration Tube EUDAMED
- Device Name
- Silicone Gastroplasty Calibration Tube EUDAMED
- Model / Reference
- 2170-3039 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182603083 EUDAMED
- Basic UDI-DI
- B-04711182603083 EUDAMED
- EMDN Code
- G020502 GASTRIC CALIBRATION TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Fortune Silicone Gastroplasty Calibration Tube 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-04711182603083 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fortune Medical Instrument Corp.
- EUDAMED SRN
- TW-MF-000009221
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 2a392bbf-1c05-4ee6-892f-bee265106ed0 61 fields · synced Jun 18, 2026