Identity
- Device Name
- Surgical Instrument EUDAMED
- Model / Reference
- AV.1650.11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04049047127857 EUDAMED
- Basic UDI-DI
- 4049047LGY03ANA27DRO5T EUDAMED
- Direct Marketing DI
- 04049047127857 EUDAMED
- EMDN Code
- L14010299 OROPHARYNGAL SURGERY INSTRUMENTS, REUSABLE - OTHER 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: Mouth gag, adjustable, reusable
Surgical Instrument by Gimmi Gmbh — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Mouth gag, adjustable, reusable.
- FENTEX — FENTEX medical GmbH · Class I
- Novo Surgical — NOVO SURGICAL, INC. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class I
- Integra® — Integra LifeSciences Production Corporation · Class I
- BR Surgical, LLC — BR SURGICAL LLC · Class I
- Ambler Surgical — Ambler Surgical, LLC · Class I
- Reicodent — devemed GmbH · Class I
- Ambler Surgical — Ambler Surgical, LLC · 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 | 4049047LGY03ANA27DRO5T | Class I | Active |
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Manufacturer
- Manufacturer
- Gimmi GmbH
- EUDAMED SRN
- DE-MF-000005445
Sources (1)
- EUDAMED 6f6236b3-bdf1-4973-8722-439238f7b4d7 61 fields · synced Jul 16, 2026