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Bite Block
EUDAMEDFDA UDIClass I (EU MDR)
Ref PN-600-03Model PN-600-01, PN-600-02, PN-600-03, PN-600-04Ref PN-600-01Ref PN-600-04Ref PN-600-02
Identity
- Trade Name
- Bite Block FDA UDI
- Generic Name
- Endoscopic bite block, basic, single-use FDA UDI
- Device Name
- Bite Block EUDAMEDA device intended to be inserted into a patient''s mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope FDA UDI
- Model / Reference
- PN-600-01, PN-600-02, PN-600-03, PN-600-04 EUDAMEDPN-600-03 EUDAMEDPN-600-01 EUDAMEDPN-600-04 EUDAMEDPN-600-02 EUDAMEDPN-600 FDA UDI
- Description
- A device intended to be inserted into a patient''s mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872108740 EUDAMED04719872108764 EUDAMEDFDA UDI04719872108733 EUDAMED04719872108757 EUDAMED
- Basic UDI-DI
- 471987210PN600CT EUDAMED
- FDA Product Code
- MNK FDA UDI
- EMDN Code
- G030804 GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS EUDAMED
- GMDN Term
- Endoscopic bite block, basic, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Bite Block by Enter Medical Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471987210PN600CT | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Enter Medical Corporation
- EUDAMED SRN
- TW-MF-000044216
- Authorised Representative
- Kingsmead Service B.V. NL-AR-000002066
Sources (5)
- EUDAMED 9750deee-c356-49ab-bc34-4e8bfcfabb33 61 fields · synced Jul 28, 2026
- EUDAMED 776e8c83-8b15-46be-8904-8c684cb89eb9 61 fields · synced May 18, 2026
- EUDAMED ac8f6f51-972c-4f24-8188-a9f87a079ee2 61 fields · synced May 18, 2026
- EUDAMED 8b780565-e929-4e9f-bb51-583f83fd5cd1 61 fields · synced May 18, 2026
- FDA UDI f5ff7d7e-ac78-4ba9-84fb-28860a6cc54a 33 fields · synced May 30, 2026