Identity
- Trade Name
- PEN EUDAMED
- Device Name
- PEN EUDAMED
- Model / Reference
- WSC65 EUDAMEDWSC68 EUDAMEDWSC69 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800017601250 EUDAMED08800017601281 EUDAMED08800017601274 EUDAMED
- Basic UDI-DI
- B-08800017601250 EUDAMEDB-08800017601281 EUDAMEDB-08800017601274 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pen by Woosung Medi-Filtech — 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-08800017601250 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Woosung Medi-Filtech
- EUDAMED SRN
- KR-MF-000004529
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (3)
- EUDAMED c8b420ec-b403-4a1f-9999-137c60f8ab1e 61 fields · synced Jul 27, 2026
- EUDAMED e251bdbf-6aa0-4362-ad54-86b2fa6258ce 61 fields · synced May 17, 2026
- EUDAMED 449add30-4b0a-4b3e-b675-22437b0a290d 61 fields · synced May 18, 2026