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Adapter Caps, 28mm longneck/T
EUDAMEDFDA UDIClass I (EU MDR)
Ref Adapter Caps, 28mm longneck/T
Identity
- Trade Name
- Health Care Logistics, Inc® FDA UDI
- Generic Name
- Medicine bottle cap FDA UDI
- Device Name
- Adapter Caps, 28mm longneck/T EUDAMEDAdapter Cap 28mm/F FDA UDI
- Model / Reference
- Adapter Caps, 28mm longneck/T EUDAMED8013-10 FDA UDI
- Description
- Adapter Cap 28mm/F FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10827989000343 EUDAMEDFDA UDI
- Basic UDI-DI
- 10827989000343QG EUDAMED
- Direct Marketing DI
- 10827989000343 EUDAMED
- FDA Product Code
- KYX FDA UDI
- EMDN Code
- A0799 ADAPTERS, CONNECTORS, RAMPS, STOPCOCKS, CAPS - OTHER EUDAMED
- GMDN Term
- Medicine bottle cap FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6430 FDA UDI
- Market of Registration
- Spain 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
Yes
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
No
FDA UDI
Adapter Caps, 28mm longneck/T by Health Care Logistics — 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 | 10827989000343QG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Health Care Logistics
- EUDAMED SRN
- US-MF-000038590
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (3)
- EUDAMED 5d928bd7-d3fe-43d1-878d-3e7edc5df369 61 fields · synced Jun 18, 2026
- FDA UDI 88302e63-ce7e-47c9-a03c-ccc7bcc16017 34 fields · synced May 30, 2026
- EUDAMED 5d928bd7-d3fe-43d1-878d-3e7edc5df369-1 61 fields · synced Jun 10, 2026