← Back to catalogue
Sterile Latex Surgical Gloves
EUDAMEDClass IIa (EU MDR)
Ref T010101Ref 2009Model 5,5.5,6,6.5,7,7.5,8,8.5,9,9.5
Identity
- Trade Name
- Sterile Latex Surgical Gloves for Single Use EUDAMED
- Device Name
- Sterile Latex Surgical Gloves EUDAMEDNON-POWDERED LATEX SURGICAL GLOVES EUDAMED
- Model / Reference
- T010101 EUDAMED5,5.5,6,6.5,7,7.5,8,8.5,9,9.5 EUDAMED2009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06949153924112 EUDAMED06949153928110 EUDAMED06949153926116 EUDAMED06949153921111 EUDAMED06949153920091 EUDAMED06949153922118 EUDAMED06949153929117 EUDAMED
- Basic UDI-DI
- B-06949153924112 EUDAMEDB-06949153928110 EUDAMEDB-06949153926116 EUDAMEDB-06949153921111 EUDAMED69491539GLOVES03JZ EUDAMEDB-06949153922118 EUDAMEDB-06949153929117 EUDAMED
- Unit of Use DI
- 06949153920015 EUDAMED
- EMDN Code
- T01010102 NON-POWDERED LATEX SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Latvia EUDAMEDItaly EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Sterile Latex Surgical Gloves by Shandong Yuyuan Latex Gloves Co., LTD. — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-06949153924112 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06949153924112 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shandong Yuyuan Latex Gloves Co., LTD.
- EUDAMED SRN
- CN-MF-000033447
- Authorised Representative
- Caretechion GmbH DE-AR-000005946
Sources (8)
- EUDAMED 5eda5164-26d9-4fe2-a1a9-33f4c79fd3ee 61 fields · synced Sep 17, 2026
- EUDAMED 4face65f-3d8b-4a45-bec6-c690ed4c84d5 61 fields · synced May 16, 2026
- EUDAMED 846e4bb9-c5d3-4a63-973f-37e01ec9d616 61 fields · synced May 17, 2026
- EUDAMED 2dd567e2-efcd-44dc-92c2-8122ca4af716 61 fields · synced May 17, 2026
- EUDAMED 91bff6c0-38dd-4b24-96aa-e76878089e94 61 fields · synced May 18, 2026
- EUDAMED 4aee0e37-8448-4605-a64c-d48d30477b7c 61 fields · synced May 19, 2026
- EUDAMED 10376ddd-69e7-4fc4-9dce-b678c8b34587 61 fields · synced May 19, 2026
- EUDAMED 599c4fba-8f10-4d31-9bb1-e4737244ff21 61 fields · synced Jun 18, 2026