Identity
- Trade Name
- EXEL 5ML CLEAR HLDR EUDAMEDEXEL Multi-Sample Luer Holder (Non-Sterile) EUDAMEDEXEL Luer Holder FDA UDI
- Generic Name
- Blood collection tube holder/needle FDA UDI
- Device Name
- Luer Holder EUDAMEDEXEL Multi-Sample Luer Holder EUDAMEDLuer Holder, Bulk, Non-Sterile FDA UDI
- Model / Reference
- 26530 EUDAMEDFDA UDI
- Description
- Luer Holder, Bulk, Non-Sterile FDA UDI
Identifiers
- Catalog Number
- 26530 FDA UDI
- Primary DI / UDI-DI
- 00020221265309 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00020221265309 EUDAMED20221HOLDER2654A EUDAMED
- FDA Product Code
- JKA FDA UDIFMH FDA UDI
- EMDN Code
- A01018001 HOLDERS FOR COLLECTION NEEDLES EUDAMED
- GMDN Term
- Blood collection tube holder/needle FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 862.1675 FDA UDI864.3250 FDA UDI
- Market of Registration
- Netherlands EUDAMEDGermany 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Exel 5ml Clear Hldr by Exelint International, Co. — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-00020221265309 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-00020221265309 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Exelint International, Co.
- EUDAMED SRN
- US-MF-000037396
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED f392dc20-b910-4219-a11f-bf4c6e6f392c 61 fields · synced Jul 16, 2026
- EUDAMED a6036659-c4d4-4576-abb7-7f3acd1f5eba 61 fields · synced May 19, 2026
- FDA UDI 7883c562-03b5-4cb6-aed8-e58ae62f42a5 35 fields · synced May 29, 2026