Identity
- Trade Name
- Coda® EUDAMEDFDA UDI
- Generic Name
- Non-respiratory device ambient air filter FDA UDI
- Device Name
- Coda® Incubator Unit EUDAMEDCoda Incubator Unit FDA UDI
- Model / Reference
- GCIU-010 EUDAMEDFDA UDI
- Description
- Coda Incubator Unit FDA UDI
Identifiers
- Catalog Number
- GCIU-010 FDA UDI
- Primary DI / UDI-DI
- 00815965020983 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00815965020983 EUDAMED
- 510(k) Number
- K001486 FDA UDI
- FDA Product Code
- MQG FDA UDI
- EMDN Code
- W02070304 CHEMICAL FILTRATION AIR CLOSETS EUDAMED
- GMDN Term
- Non-respiratory device ambient air filter FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 884.6120 FDA UDI
- Market of Registration
- Northern Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Coda® by LifeGlobal Group, LLC — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00815965020983 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- LifeGlobal Group, LLC
- EUDAMED SRN
- US-MF-000015291
- Authorised Representative
- CooperSurgical Distribution B.V. NL-AR-000000059
Sources (2)
- EUDAMED 75f34031-18e9-4cd2-8495-542f1663d25a 61 fields · synced Jun 9, 2026
- FDA UDI 8a0f0ac8-f6b1-44aa-aa91-9b6e1aba7529 37 fields · synced May 30, 2026