← Back to catalogue
Peha-soft Disposable Nitrile Gloves, 3.5g，Powder-free, Blue, S size
EUDAMEDClass I (EU MDR)
Ref 942012Model EM0102Ref 942014Ref 942015Ref 942027Ref 942013Ref 942029Ref 942011
Identity
- Trade Name
- Peha-soft Disposable Nitrile Gloves,3.5g，Powder-free, Blue, S size EUDAMEDPeha-soft Disposable Nitrile Gloves,3.5g，Powder-free, Blue, L size EUDAMEDPeha-soft Disposable Nitrile Gloves,3.5g，Powder-free, Blue, XL size EUDAMEDPeha-soft Disposable Nitrile Gloves,3.5g，Powder-free, Blue, M size EUDAMEDPeha-soft Disposable Nitrile Gloves,3.5g，Powder-free, Blue, XS size EUDAMED
- Device Name
- Disposable Nitrile Examination Gloves, Powder Free EUDAMED
- Model / Reference
- EM0102 EUDAMED942012 EUDAMED942014 EUDAMED942015 EUDAMED942027 EUDAMED942013 EUDAMED942029 EUDAMED942011 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06933265500029 EUDAMED06933265500067 EUDAMED06933265500074 EUDAMED06933265559874 EUDAMED06933265500050 EUDAMED06933265559898 EUDAMED06933265500005 EUDAMED
- Basic UDI-DI
- 69332655EM01021562864B EUDAMED
- Direct Marketing DI
- 06933265500029 EUDAMED06933265500067 EUDAMED06933265500074 EUDAMED06933265559874 EUDAMED06933265500050 EUDAMED06933265559898 EUDAMED06933265500005 EUDAMED
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Peha-soft Disposable Nitrile Gloves, 3.5g，Powder-free, Blue, S size by Blue Sail Medical Co., Ltd — Class I — MDR — listed in EUDAMED
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 | 69332655EM01021562864B | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Blue Sail Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000001139
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (7)
- EUDAMED ddc18f8d-d2fa-43d0-92b3-c97bfa573ac5 61 fields · synced Aug 5, 2026
- EUDAMED 0374b421-35db-43ae-bf59-62aa24209608 61 fields · synced May 16, 2026
- EUDAMED 05f9acd4-0475-4860-a226-e1487c2f6413 61 fields · synced May 17, 2026
- EUDAMED b6ce2b9c-c1fa-488b-b0c2-a1e5204c8b47 61 fields · synced May 17, 2026
- EUDAMED 6594a0f8-c59c-4b2c-b94c-7a0f55ccde85 61 fields · synced May 17, 2026
- EUDAMED 932d1aef-a772-4453-9d3c-b812050b8134 61 fields · synced May 18, 2026
- EUDAMED 3c319f0c-5dd0-480f-99a0-39242c3b4027 61 fields · synced May 18, 2026