Identity
- Trade Name
- Holder EUDAMED
- Device Name
- Holder EUDAMED
- Model / Reference
- XLC EUDAMEDXLC1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950383640000 EUDAMED
- Basic UDI-DI
- 69503836XL1001C1ME EUDAMED
- Unit of Use DI
- 86950383640006 EUDAMED
- EMDN Code
- A01018001 HOLDERS FOR COLLECTION NEEDLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Holder by Hebei Xinle Sci&Tech Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69503836XL1001C1ME | Class I | Active |
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Manufacturer
- Manufacturer
- Hebei Xinle Sci&Tech Co., Ltd
- EUDAMED SRN
- CN-MF-000016692
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d3efdc3d-e287-459b-9185-45dd6dae42d8 61 fields · synced Aug 3, 2026