Identity
- Device Name
- Equipment Covers EUDAMED
- Model / Reference
- 25-3613-S1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16931918126241 EUDAMED
- Basic UDI-DI
- 69319181F008KZ EUDAMED
- EMDN Code
- T030101 COVER CAPS, INSTRUMENTS AND EQUIPMENT EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Vascular booties
Equipment Covers by GRI Medical & Electronic Technology Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Vascular booties.
- Sterile protective cover N°163 DE1 — ARMOR d.o.o. AZANJA · Class I
- TIP COVERS — SONTEC INSTRUMENTS, INC. · Class I
- Dome Bag — Exact Medical Manufacturing, Inc · Class I
- STERINORM® Bodennaht-Beutel — Udo Heisig GmbH The Disposables Company · Class I
- STERINORM® Spangenbezug C-SET — Udo Heisig GmbH The Disposables Company · Class I
- NP180 — SUZHOU DUKANGNING MEDICAL PRODUCTS CO., LTD · Class I
- Positioning pillow protective cover — Cobes Industries(Hefei) Co.,Ltd · Class I
- Scanlan® SURG-I-PAW® Instrument Covers — SCANLAN INTERNATIONAL INC · Class I
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 | 69319181F008KZ | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- GRI Medical & Electronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000004203
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 91cb0b5f-4484-4595-bc1d-a61ea344b5a0 61 fields · synced Sep 18, 2026