Identity
- Trade Name
- Penguin ENT Scope model FDA UDI
- Generic Name
- Otoscope, direct FDA UDI
- Device Name
- Penguin Scope is an outstanding medical innovation designed specifically for comprehensive ear examinations. This device is trusted by medical professionals around the world, and its unique design allows for deep penetration into the ear canal and examination of the eardrum, with multiple uses: Penguin Scope can help you detect potential ear infections, earwax buildup, and foreign object invasion. Penguin Scope can regularly assess ear health, which is particularly beneficial for ears that are prone to problems. Penguin Scope cleanses hearing aid equipment to provide peace of mind by maintaining performance and hygiene. Penguin Scope can provide remote medical support, provide initial assessments for professionals, and assist them in making medical treatment decisions. FDA UDI
- Model / Reference
- CP1313F6 FDA UDI
- Description
- Penguin Scope is an outstanding medical innovation designed specifically for comprehensive ear examinations. This device is trusted by medical professionals around the world, and its unique design allows for deep penetration into the ear canal and examination of the eardrum, with multiple uses: Penguin Scope can help you detect potential ear infections, earwax buildup, and foreign object invasion. Penguin Scope can regularly assess ear health, which is particularly beneficial for ears that are prone to problems. Penguin Scope cleanses hearing aid equipment to provide peace of mind by maintaining performance and hygiene. Penguin Scope can provide remote medical support, provide initial assessments for professionals, and assist them in making medical treatment decisions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04711099370047 FDA UDI
- FDA Product Code
- ERA FDA UDI
- GMDN Term
- Otoscope, direct FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4770 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Otoscope, direct
Penguin ENT Scope model by Opcom Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
- Safety 1st — DOREL JUVENILE GROUP, INC. · Class I
- BETA 200 VET. OTOSCOPE — Heine Optotechnik GmbH & Co. KG · Class I
- Firefly — Firefly Global · Class I
- Otoscope — Shenzhen Teslong Technology Co., Ltd · Class I
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Opcom Inc.
Sources (1)
- FDA UDI ebe95b8f-a192-40ed-a6d5-8520e1e1f83d 33 fields · synced May 31, 2026