Identity
- Trade Name
- Pennamed EUDAMED
- Device Name
- Bite Block Strap EUDAMED
- Model / Reference
- PEN-STRAP-2636 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08682952412432 EUDAMED
- Basic UDI-DI
- B-08682952412432 EUDAMED
- EMDN Code
- G0380 DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Gastro-urological guidewire, single-use
Pennamed by Pergo Medikal ve Ilac Sanayi A.S. — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Gastro-urological guidewire, single-use.
- ZKSK — Beijing ZKSK Technology Co., Ltd · Class II
- aneopiston — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
- Tracer Metro — COOK INCORPORATED · Class II
- Sterile Hydro-Slide Guidewire — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Single Use Urinary Guidewire — Zhejiang Chuangxiang Medical Technology Co., LTD. · Class II
- Führungsdraht, "Grip-Wire", Nitinol — MTW - Endoskopie W. Haag KG · Class IIa
- Disposable Endoscopy Adapter Set — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
- Valve Kit for PENTAX — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08682952412432 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pergo Medikal ve Ilac Sanayi A.S.
- EUDAMED SRN
- TR-MF-000020761
Sources (1)
- EUDAMED 11da4caf-b5db-46c4-9772-43443ed1f5f8 61 fields · synced Oct 6, 2026