Identity
- Device Name
- Silicone Reservoir EUDAMED
- Model / Reference
- 100ml、200ml、400ml EUDAMED200ML EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926767206315 EUDAMED
- Basic UDI-DI
- 69267672010XA EUDAMED
- EMDN Code
- A0680 DRAINAGE AND FLUID COLLECTION DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Silicone Reservoir by Shandong Steve Medical Science & Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69267672010XA | Class I | Active |
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Manufacturer
- EUDAMED SRN
- CN-MF-000034622
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (1)
- EUDAMED 3de772f6-f4a5-4073-86cb-dbf2c43879dc 61 fields · synced Oct 6, 2026