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Fora-B
EUDAMEDClass IIb (EU MDR)
Ref COB30U-1Ref SWECB-CS-03Ref SWECB-CS-04Ref COB20S-2
Identity
- Trade Name
- FORA-B EUDAMEDFORA-B TF EUDAMED
- Device Name
- FORA-B & FORA-B TF EUDAMED
- Model / Reference
- COB30U-1 EUDAMEDSWECB-CS-03 EUDAMEDSWECB-CS-04 EUDAMEDCOB20S-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809272563235 EUDAMED08809272562528 EUDAMED08809272562788 EUDAMED08809272563259 EUDAMED
- Basic UDI-DI
- B-08809272563235 EUDAMEDB-08809272562528 EUDAMEDB-08809272562788 EUDAMEDB-08809272563259 EUDAMED
- EMDN Code
- N02010102 PERIDURAL / EPIDURAL CATHETERS FOR CONTINUOUS ANALGESIA AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Fora-B by Seawon Meditech Co., Ltd. — Class IIb — 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-08809272563235 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Seawon Meditech Co., Ltd.
- EUDAMED SRN
- KR-MF-000007442
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (4)
- EUDAMED f574024c-13ca-4657-97c5-57afa2f0edef 61 fields · synced Jul 24, 2026
- EUDAMED a3ec351c-588c-4f47-bff8-66e01f613673 61 fields · synced May 17, 2026
- EUDAMED dca4d96f-1944-4c14-9e2f-e0b7d2cf8929 61 fields · synced May 18, 2026
- EUDAMED 1dc27669-4ae0-45bd-97dc-8bda63742858 61 fields · synced May 18, 2026