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AeroGuard ‘Jellyfish’
EUDAMEDFDA UDIClass I (EU MDR)
Ref 2000.2000
by medaxis AG
Identity
- Trade Name
- debritom+ FDA UDI
- Generic Name
- Surgical irrigation system nozzle FDA UDI
- Device Name
- AeroGuard ‘Jellyfish’ EUDAMEDdebritom+ AeroGuard "Jellyfish" FDA UDI
- Model / Reference
- 2000.2000 EUDAMEDFDA UDI
- Description
- debritom+ AeroGuard "Jellyfish" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07649996166159 EUDAMEDFDA UDI
- Basic UDI-DI
- 76499961662000JellyfishTX EUDAMED
- FDA Product Code
- FQH FDA UDI
- EMDN Code
- Z12019003 WOUND TREATMENT EQUIPMENT EUDAMED
- GMDN Term
- Surgical irrigation system nozzle FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
AeroGuard ‘Jellyfish’ by Medaxis AG — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 76499961662000JellyfishTX | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- medaxis AG
- EUDAMED SRN
- CH-MF-000011487
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 28918b32-d896-4dfd-ae6e-8fb026946fc4 61 fields · synced Jul 30, 2026
- FDA UDI 7e61cd89-6f4f-4b9d-ae49-ee7ecf457531 34 fields · synced May 30, 2026