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Sterile Latex Surgical Gloves
EUDAMEDClass IIa (EU MDR)
Ref CE/MDR-AY-03Model Powder- Free 6Model Powder- Free 8Model Pre-Powdered 8Model Pre-Powdered 7.5Model Powder- Free 9Model Pre-Powdered 7Model Pre-Powdered 9
Identity
- Trade Name
- Sterile Latex Surgical Gloves EUDAMED
- Device Name
- Sterile Latex Surgical Gloves EUDAMED
- Model / Reference
- Powder- Free 6 EUDAMEDCE/MDR-AY-03 EUDAMEDPowder- Free 8 EUDAMEDPre-Powdered 8 EUDAMEDPre-Powdered 7.5 EUDAMEDPowder- Free 9 EUDAMEDPre-Powdered 7 EUDAMEDPre-Powdered 9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06928965100006 EUDAMED06928965100044 EUDAMED06928965100112 EUDAMED06928965100105 EUDAMED06928965100068 EUDAMED06928965100099 EUDAMED06928965100136 EUDAMED
- Basic UDI-DI
- B-06928965100006 EUDAMEDB-06928965100044 EUDAMEDB-06928965100112 EUDAMEDB-06928965100105 EUDAMEDB-06928965100068 EUDAMEDB-06928965100099 EUDAMEDB-06928965100136 EUDAMED69289651SLS022L EUDAMED69289651SLS012J EUDAMED
- EMDN Code
- T01010102 NON-POWDERED LATEX SURGICAL GLOVES EUDAMEDT01010101 POWDERED LATEX SURGICAL GLOVES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMEDSpain 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 Anhui Anyu Latex Products 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-06928965100006 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06928965100006 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Anhui Anyu Latex Products Co., Ltd
- EUDAMED SRN
- CN-MF-000030048
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (14)
- EUDAMED 168e92b3-83b2-46a0-96ae-d6e5e66f7df7 61 fields · synced Oct 6, 2026
- EUDAMED 74e3488d-1d45-4f87-abb8-480a94111a95 61 fields · synced May 16, 2026
- EUDAMED 58d885d9-fb6c-4e3d-b648-9d2eff2d5db4 61 fields · synced May 17, 2026
- EUDAMED 1ef3c205-98a6-44fa-9d0e-98efedfcbdfa 61 fields · synced May 19, 2026
- EUDAMED 46176d65-5ecd-49fe-9af0-b5bed82ab4fc 61 fields · synced May 19, 2026
- EUDAMED 77bde491-1888-4790-b64c-93b32ee50734 61 fields · synced May 19, 2026
- EUDAMED de356890-1936-43e4-946d-adf8e1395666 61 fields · synced May 19, 2026
- EUDAMED 1f02c298-7689-47a2-8e2e-238f03db1dc6 61 fields · synced Jul 10, 2026
- EUDAMED a4aee904-3573-42c8-8af6-0e2954d34577 61 fields · synced Jul 10, 2026
- EUDAMED 2676ddff-8f04-459f-8e8d-f9bb66c03d55 61 fields · synced Jul 11, 2026
- EUDAMED 66873bc3-da34-48c1-8d03-9598dbd4fa23 61 fields · synced Jul 11, 2026
- EUDAMED 00ac60cc-4f03-467c-9097-f6ee80554977 61 fields · synced Jul 12, 2026
- EUDAMED 0ad03b96-d761-4259-b98c-cee8c931d0f3 61 fields · synced Aug 3, 2026
- EUDAMED abcc2f6d-abec-4238-a27a-30db34fd52eb 61 fields · synced Sep 17, 2026