Identity
- Trade Name
- Health Care Logistics, Inc® FDA UDI
- Generic Name
- Medicine bottle cap FDA UDI
- Device Name
- Adapter Caps, 38mm/I EUDAMEDAdapter Cap 38mm/I FDA UDI
- Model / Reference
- Adapter Caps, 38mm/I EUDAMED19541 FDA UDI
- Description
- Adapter Cap 38mm/I FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10827989003429 EUDAMEDFDA UDI
- Basic UDI-DI
- 10827989003429RG EUDAMED
- Direct Marketing DI
- 10827989003429 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
No
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
No
FDA UDI
Adapter Caps, 38mm/I 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 | 10827989003429RG | 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 d571048e-ecf4-4498-b32b-10c3188fa057 61 fields · synced Jul 14, 2026
- FDA UDI 45ed09d7-266a-4262-9274-65f9c705b675 34 fields · synced May 30, 2026
- EUDAMED d571048e-ecf4-4498-b32b-10c3188fa057-1 61 fields · synced Jun 10, 2026