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N65b10
EUDAMEDClass I (EU MDR)
Ref N65B10Model HDPE Glove Blocked, HDPE Glove With Paper Header, HDPE Glove Box-Packed, HDPE Glove Bag-Packed, LDPE Glove Blocked, LDPE Glove With Paper Header, LDPE Glove Box-Packed, LDPE Glove Bag-Packed, TPE Glove, LDPE Glove with Long Sleeve, PVC Glove, etc
Identity
- Model / Reference
- HDPE Glove Blocked, HDPE Glove With Paper Header, HDPE Glove Box-Packed, HDPE Glove Bag-Packed, LDPE Glove Blocked, LDPE Glove With Paper Header, LDPE Glove Box-Packed, LDPE Glove Bag-Packed, TPE Glove, LDPE Glove with Long Sleeve, PVC Glove, etc EUDAMEDN65B10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974424848651 EUDAMED
- Basic UDI-DI
- 697442484L07QK EUDAMED
- EMDN Code
- T010299 EXAMINATION / TREATMENT GLOVES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
N65b10 by Leboo Healthcare Products Limited — 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 | 697442484L07QK | Class I | Active |
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Manufacturer
- Manufacturer
- Leboo Healthcare Products Limited
- EUDAMED SRN
- CN-MF-000008521
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 2b701d29-0b41-4baa-b6e0-ab7876e0ff31 61 fields · synced Oct 6, 2026