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DonorCare® Needle Guard Large Channel
EUDAMEDFDA UDIClass I (EU MDR)
Ref A100150
Identity
- Trade Name
- DonorCare® Needle Guard Large Channel EUDAMEDFDA UDI
- Generic Name
- Needle guard FDA UDI
- Device Name
- Needle Guard EUDAMEDDonorCare® Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures. FDA UDI
- Model / Reference
- A100150 EUDAMEDFDA UDI
- Description
- DonorCare® Needle Guard is intended to aid in the prevention of accidental needle stick injuries upon completion of blood collection procedures. FDA UDI
Identifiers
- Catalog Number
- A100150 FDA UDI
- Primary DI / UDI-DI
- 19555240400151 EUDAMEDFDA UDI
- Basic UDI-DI
- 955524040NGNSHU EUDAMED
- FDA Product Code
- KSS FDA UDI
- EMDN Code
- A018001 NEEDLE CAPS EUDAMED
- GMDN Term
- Needle guard FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 864.9050 FDA UDI
- Market of Registration
- Türkiye 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
DonorCare® Needle Guard Large Channel by Itl Asia Pacific Sdn. Bhd. — 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 | 955524040NGNSHU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ITL Asia Pacific Sdn. Bhd.
- EUDAMED SRN
- MY-MF-000001570
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 0a8245eb-8a10-4d0c-a9f2-47c8cb5e24e4 61 fields · synced Jun 19, 2026
- FDA UDI 4a855c84-4c36-4e63-a8d7-debee7e9ce8a 37 fields · synced May 29, 2026