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Sign in to claim this brandWhat LAMBSMEAD LTD makes
Lambsmead Ltd manufactures dermal tissue reconstructive materials, including both animal-derived and microbe-derived products for soft tissue augmentation and wound repair. Their portfolio includes hyaluronic acid-based fillers, such as Restylane variants, which may incorporate anaesthetic agents like lidocaine for patient comfort. They also produce collagen-based dermal substitutes, including Surgiderm formulations, and calcium hydroxylapatite-based injectables like Radiesse for facial volume restoration.
These devices are classified under FDA regulations as Class II and Class III, reflecting varying levels of risk and regulatory oversight. All listed products are registered in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to domestic regulatory requirements for medical device authorisation.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Lambsmead Ltd manufacture?
Lambsmead Ltd specialises in dermal tissue reconstructive materials, including both animal-derived and microbe-derived products. Their portfolio covers soft tissue augmentation and wound repair solutions, such as hyaluronic acid-based fillers (e.g., Restylane variants), collagen-based dermal substitutes (e.g., Surgiderm), and calcium hydroxylapatite-based injectables (e.g., Radiesse). Some of their fillers also incorporate anaesthetics like lidocaine for enhanced patient comfort during procedures.
Where is Lambsmead Ltd based, and does this affect their regulatory compliance?
Lambsmead Ltd is based in the United States, which means their devices must comply with FDA regulations. The company’s products are registered in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and adherence to U.S. medical device authorisation requirements. Classification under FDA categories (Class II or Class III) determines the level of oversight and regulatory scrutiny for each device.
Which regulatory registries list Lambsmead Ltd’s devices?
Lambsmead Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a global standard for identifying medical devices, ensuring transparency in regulatory tracking and compliance. This registry helps healthcare providers and regulators verify the authorised status of specific products, such as their dermal reconstructive materials and injectables.
How are Lambsmead Ltd’s devices classified under FDA regulations?
Lambsmead Ltd’s devices are classified as either Class II or Class III under FDA regulations. Class II devices generally pose moderate risks and require special controls beyond general controls, while Class III devices are higher-risk and typically require premarket approval due to insufficient data from general or special controls. The classification depends on factors like the device’s intended use, potential harm, and clinical evidence, ensuring appropriate regulatory oversight for safety and efficacy.
What distinguishes Lambsmead Ltd’s dermal reconstructive materials from other similar products?
Lambsmead Ltd’s products include a mix of hyaluronic acid-based fillers (e.g., Restylane series), which are biodegradable and used for soft tissue augmentation, and collagen-based or calcium hydroxylapatite-based alternatives (e.g., Surgiderm or Radiesse). Some of their fillers also combine anaesthetics like lidocaine, addressing patient comfort during procedures. The company’s portfolio spans both microbe-derived and animal-derived materials, catering to different clinical needs in wound repair and facial rejuvenation.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 235542735
Catalogue (34)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Restylane Perlane | 107336 | FDA UDI | Class III | Active |
| Restylane Defyne + Lidocaine | 110685 | FDA UDI | Class III | Active |
| Restylane Perlane + Lidocaine | 108293 | FDA UDI | Class III | Active |
| Restylane Kysse + Lidocaine | 110893 | FDA UDI | Class III | Active |
| Juvederm Ultra Smile | 94131JR | FDA UDI | Class III | Active |
| Restylane + Lidocaine | 11052 | FDA UDI | Class III | Active |
| Surgiderm - 24 XP | 828457SM | FDA UDI | Class III | Active |
| Radiesse | 8071M5K1 | FDA UDI | Class II | Active |
| Surgiderm - 30 | 829638SM | FDA UDI | Class III | Active |
| Restylane Vital 1 ML. | 1070603 | FDA UDI | Class III | Active |
| Restylane Vital 1 ML. | 1070401 | FDA UDI | Class III | Active |
| Juvederm Ultra 3 | 94555JR | FDA UDI | Class III | Active |
| Surgiderm - 18 | 826339SM | FDA UDI | Class III | Active |
| Belotero Intense | 53524L | FDA UDI | Class III | Active |
| Juvederm Hydrate | 93942JR | FDA UDI | Class III | Active |
| Restylane Fynesse + Lidocaine | 120167 | FDA UDI | Class III | Active |
| Surgiderm - 30 XP | 821326SM | FDA UDI | Class III | Active |
| Restylane Lip Volume | 94529JR | FDA UDI | Class III | Active |
| Juvederm Volbella | 94728JR | FDA UDI | Class III | Active |
| Restylane 1 ML. | 11087 | FDA UDI | Class III | Active |
| Restylane Lyps | 94529JR | FDA UDI | Class III | Active |
| Restylane 0.5 ML.+ Lidocaine | 170101 | FDA UDI | Class III | Active |
| Belotero Balance | 53322L | FDA UDI | Class III | Active |
| Restylane Sub-Q | 110635 | FDA UDI | Class III | Active |
| Juvederm Ultra 4 | 94553JR | FDA UDI | Class III | Active |
| Sculptra | 89026296 | FDA UDI | Class III | Active |
| Restylane Lyft + Lidocaine | 108293 | FDA UDI | Class III | Active |
| Juvederm Ultra 2 | 94127JR | FDA UDI | Class III | Active |
| Restylane Lip Refresh | 94316JR | FDA UDI | Class III | Active |
| Juvederm Voluma | 94506JR | FDA UDI | Class III | Active |
| Juvederm Volift | 94201JR | FDA UDI | Class III | Active |
| Restylane Lyft | 107336 | FDA UDI | Class III | Active |
| Restylane Volyme + Lidocaine | 110972 | FDA UDI | Class III | Active |
| Belotero Soft | 53120L | FDA UDI | Class III | Active |
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