Identity
- Trade Name
- Bisshilfe-Streifen EUDAMED
- Device Name
- Bisshilfe-Streifen EUDAMED
- Model / Reference
- 596020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +ERKO5960201 EUDAMED
- Basic UDI-DI
- ++ERKO081NNNNN1209BY EUDAMED
- Unit of Use DI
- 1 EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - 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
Bisshilfe-Streifen by Erkodent Erich Kopp Gmbh — 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 | ++ERKO081NNNNN1209BY | Class I | Active |
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Manufacturer
- Manufacturer
- Erkodent Erich Kopp GmbH
- EUDAMED SRN
- DE-MF-000006243
Sources (1)
- EUDAMED ade3c357-21d0-408e-8b7c-ce354bffa709 61 fields · synced Jul 27, 2026