Identity
- Trade Name
- Ovaleap Pen EUDAMED
- Device Name
- Ovaleap Pen EUDAMED
- Model / Reference
- P002604A3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016189260413 EUDAMED
- Basic UDI-DI
- 5016189OVALEAPXA EUDAMED
- EMDN Code
- A018006 HYPODERMIC NEEDLES PEN INJECTORS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Estonia 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
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Ovaleap Pen by Owen Mumford Ltd — 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 | 5016189OVALEAPXA | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Owen Mumford Ltd
- EUDAMED SRN
- GB-MF-000021000
- Authorised Representative
- Owen Mumford GmbH DE-AR-000020700
Sources (1)
- EUDAMED b14039c3-b114-4d6f-a91c-1b2700b99a33 61 fields · synced Jun 18, 2026