Identity
- Trade Name
- Elastic barrier strips EUDAMED
- Device Name
- Non-sterile Ostomy Appliances EUDAMED
- Model / Reference
- 2022300 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06926515481551 EUDAMED
- Basic UDI-DI
- 69593857NOA000006AU EUDAMED
- EMDN Code
- A108099 ACCESSORY DEVICES FOR ABDOMINAL OSTOMY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
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
Elastic barrier strips by Zhende Medical 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 | 69593857NOA000006AU | Class I | Active |
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Manufacturer
- Manufacturer
- Zhende Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000009961
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 742b3e9c-f9d1-4b4d-8fe8-2a064330df6b 61 fields · synced Jun 18, 2026