Identity
- Trade Name
- Dako Omnis Waste Container 7 L EUDAMEDDako FDA UDI
- Generic Name
- Laboratory waste receptacle IVD FDA UDI
- Device Name
- Dako Omnis Waste Container 7 L EUDAMEDFDA UDI
- Model / Reference
- GC118 EUDAMEDFDA UDIGC11830 EUDAMED
- Description
- Dako Omnis Waste Container 7 L FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05700571112182 EUDAMEDFDA UDI
- Basic UDI-DI
- 570057P3007P3010A051301N7 EUDAMED
- FDA Product Code
- KPA FDA UDI
- EMDN Code
- W0202059085 VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - CONSUMABLES EUDAMED
- GMDN Term
- Laboratory waste receptacle IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.3800 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 7 Liter FDA UDI
Category: Laboratory waste receptacle IVD
Dako by Agilent Technologies Singapore Pte Ltd — Class I — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Agilent Technologies Singapore Pte Ltd
Sources (2)
- FDA UDI 2a9b7d2b-e341-4bce-8560-cc28df093424 36 fields · synced Jul 9, 2026
- EUDAMED 6195e5de-10e6-4326-add6-703632ec3141 61 fields · synced Jul 9, 2026