Identity
- Device Name
- Accufuser Plus EUDAMED
- Model / Reference
- SM2008L EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-SM2008LS9 EUDAMED
- Basic UDI-DI
- B-SM2008LS9 EUDAMED
- EMDN Code
- A05010102 ELASTOMERIC SYSTEMS - FIXED FLOW WITH ADDITIONAL BOLUS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Accufuser Plus, a medical device designed for the treatment of endocrine disorders. Accufuser Plus is an Obelis s.a. product that uses a unique mechanism to deliver hormones and medications.
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-SM2008LS9 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Woo Young Medical Co., Ltd.
- EUDAMED SRN
- KR-MF-000022134
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 1a9d6e79-37eb-4c08-a3cc-d49946e5af6f 61 fields · synced Jul 19, 2026