Identity
- Device Name
- Surgical Instrument EUDAMED
- Model / Reference
- PU.1678.03 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049047074816 EUDAMED
- Basic UDI-DI
- 4049047ZCD03ANA27DROWP EUDAMED
- Direct Marketing DI
- 04049047074816 EUDAMED
- EMDN Code
- Z12020603 PROCTOSCOPES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Category: Sphincteroscope
Surgical Instrument by Gimmi Gmbh — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Sphincteroscope.
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- Gimmi — Gimmi GmbH · Class I
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 | 4049047ZCD03ANA27DROWP | Class I | Active |
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Manufacturer
- Manufacturer
- Gimmi GmbH
- EUDAMED SRN
- DE-MF-000005445
Sources (1)
- EUDAMED df35c192-c634-4e5e-8106-1305eaea471c 61 fields · synced Jun 18, 2026