Identity
- Trade Name
- UniTip Applicator EUDAMED
- Device Name
- UniTip applicator EUDAMED
- Model / Reference
- ESA010146-14 (UT0014) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04251121113728 EUDAMED
- Basic UDI-DI
- 42511211TD14BJ EUDAMED
- EMDN Code
- W0202029099 VARIOUS HEMOSTASIS INSTRUMENTS - 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
UniTip Applicator by H.+H. Maslanka Chirurgische Instrumente 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 | 42511211TD14BJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- H. + H. Maslanka Chirurgische Instrumente GmbH
- EUDAMED SRN
- DE-MF-000005600
Sources (1)
- EUDAMED d7d376c5-2636-4b15-a40f-947ba48f375b 61 fields · synced Aug 3, 2026