Identity
- Trade Name
- PEGA® SPIKE EUDAMED
- Device Name
- PEGA® SPIKE EUDAMED
- Model / Reference
- 10530 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260537490033 EUDAMED
- Basic UDI-DI
- 42605374910530MG EUDAMED426053749PSPK01F2 EUDAMED
- EMDN Code
- A99 DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Pega® Spike by Venner Medical (Deutschland) GmbH — Class IIa — 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 | 42605374910530MG | Class IIa | Active |
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Manufacturer
- Manufacturer
- Venner Medical (Deutschland) GmbH
- EUDAMED SRN
- DE-MF-000005934
Sources (2)
- EUDAMED b481e8c8-3f7e-48bd-aa36-4ac24ebc3616 61 fields · synced Oct 6, 2026
- EUDAMED 61f107b7-cf60-4b96-aeaa-223d4a7fcc4a 61 fields · synced Jul 15, 2026