Identity
- Trade Name
- Silicone Clamp Jaw Cover EUDAMED
- Device Name
- Silicone Clamp Jaw Cover EUDAMED
- Model / Reference
- 9002-SR250 EUDAMED9002-MW410 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711182608187 EUDAMED
- Basic UDI-DI
- 471096193131101FZ EUDAMEDB-04711182608187 EUDAMED
- EMDN Code
- H038099 CLIPS FOR HEMOSTASIS - ACCESSORIES OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Silicone Clamp Jaw Cover by Fortune Medical Instrument Corp. — Class I — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 471096193131101FZ | Class I | Active |
| EUDAMED | European Union | CE/MDR | 471096193131101FZ | Class I | 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 (2)
- EUDAMED 3b1ba510-d4a0-497f-823d-8e72c19268f7 61 fields · synced Jul 19, 2026
- EUDAMED 1b38fe12-a27e-4ec6-97ea-466f484e3d6a 61 fields · synced Jul 19, 2026